A Wake-up Call? Radical Action for Smarter Medicine Access

By Sofia Radley-Searle, COO of Axmed 

For decades, global health procurement – on which over six billion people depend – has mostly relied on one system: centralized multilateral institutions pooling donor funding to purchase and distribute medicines across low- and middle-income countries. While this model has delivered significant successes in certain regions and therapeutic areas, it has simultaneously perpetuated inefficiencies, including bureaucratic hurdles, misaligned priorities, inflexible procurement processes, and an unsustainable reliance on external philanthropic funding.

Now, this system is unraveling. 

The recent dramatic pullback in funding from major donors, such as USAID and the UK Government, has dealt a severe blow to global health initiatives, forcing deep budget cuts across multilateral organizations. The consequences are not abstract – they will be measured in lost lives. In Kenya, 1.4 million people living with HIV are at risk as $34 million worth of antiretroviral medicine shipments remain stranded in warehouses. In Ethiopia’s Tigray region, over 2.4 million people who relied on USAID for food now face critical shortages, with hunger accelerating the spread of preventable diseases. In Uganda, malaria deaths, already a leading cause of child mortality, are set to rise as mosquito control and treatment programs collapse. Across multiple countries, the withdrawal of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) has left millions without access to HIV testing, treatment, or even basic prevention.

For too long, medicine procurement has been driven by well-intentioned foreign budgets rather than by the needs of local communities. When this external aid disappears, medicines vanish alongside it, leaving entire health systems vulnerable and struggling to cope. The continent of Africa, for example, still bears 24% of the world’s disease burden, yet houses only 1% of global health expenditure. Less than half of Africans – just 48% – can access the healthcare services they need. 

These are not temporary challenges; it is a systemic failure that demands urgent and radical change. The current funding crisis is not the origin of the problem; rather, it simply accelerates an issue that has persisted for decades.

I wonder, has the system crumbled enough to finally compel us to rethink medicine procurement entirely? What if, instead of clinging to a crumbling multilateral model, we embraced a decentralized yet coordinated, market-driven approach? Or, as our CEO Emmanuel has called it, a ‘co-ordilateral’ approach? 

It is time we dared to imagine, and build, a world where fragmented, inefficient procurement cycles are replaced by digital platforms that match demand and supply in real-time, eliminating costly delays and unnecessary complexities. A world that moves beyond slow, top-down interventions driven by foreign political forces, toward procurement that is market-responsive, with empowered governments equipped with the right technology and affordable capital to make the right decisions.

At Axmed we are building the infrastructure to propel this shift. Our groundbreaking B2B marketplace connects healthcare procurers with pre-qualified manufacturers, digitally coordinating national and international at-scale pooled procurement. It lays the foundation for a co-ordilateral world—one that fosters transparency, unlocks innovative financing, and digitizes LMICs’ purchasing power, delivering economies of scale that drive affordability for procurers and efficiency for manufacturers, transforming the way medicines get sourced and distributed. The outdated, manual procurement systems are no longer defensible when technology offers a smarter, faster, and more resilient alternative.

The urgency of this transition was evident at the recent Axmed Access Summit in Nairobi, themed “Unlocking Access, Transforming Lives.” Unlike traditional forums, it took a bold, solutions-driven stance, confronting structural barriers and proposing radical new strategies to improve medicine availability, affordability, and quality across the continent.

By convening leaders with the power to act – government leaders, healthcare procurers, business executives, and civil society – the summit underscored a fundamental shift: moving away from reliance on multilateral systems toward localized, accountable action, empowering individual market players who can drive real change.

For too long, Africa’s healthcare challenges have been framed as insurmountable. While deep-rooted barriers such as market fragmentation, regulatory complexity, supply chain inefficiencies, weak infrastructure, and financial constraints persist, real targeted solutions already exist. Technology-enabled platforms, digital pooled procurement, data-driven forecasting, and new financing mechanisms are no longer theoretical concepts; they are active interventions reshaping healthcare systems. 

The pullback in donor funding should not be seen as an excuse for inaction; rather, it is a catalyst for transformation. The resolve shown by stakeholders in response to the recent funding crunch presents a unique opportunity for coordinated, meaningful change.

By treating healthcare as a fundamental right and embracing data-driven, tech-enabled, anticipatory business models, we can ensure more medicines reach those who need them, when they need them. 

Africa’s healthcare market represents an opportunity exceeding $300 billion in the coming years. No patient should have to walk miles for medicine; no child should suffer from preventable inaccessibility. Too many lives are lost; not because medicines are unavailable, but because they remain trapped in supply chains designed for aid rather than sustainable, long-term access.

Unprecedented progress will not come from clinging to a past that may never return. It will come from smart, tech-driven coordination, direct market engagement, and stakeholders taking full ownership of the solution and taking decisive action to innovate. 

We can fix this. Technology, ideas, and frameworks to make this shift happen already exist. What is missing? The decisive determination of stakeholders to break free from outdated systems and embrace smarter, faster, market-enabled solutions. Radical change will come from bold leaders committed to transforming the system, starting today.

Emcure and Axmed Unite to Combat Maternal and Newborn Mortality: A Bold Step Toward Equitable Healthcare Access

Basel, Switzerland, 6th March 2025 – In a bold and transformative step to tackle one of the most urgent global health challenges, Emcure Pharmaceuticals Ltd., a leading Indian pharma company, and Axmed, a pioneering B2B medicines marketplace dedicated to serving low- and middle-income countries (LMICs), have joined forces to combat the devastating burden of maternal and newborn mortality in these underserved regions.

This new partnership expands access to Ferric Carboxy Maltose (FCM), a rapid-acting intravenous iron therapy crucial for treating severe iron deficiency anemia, particularly in expectant mothers. Through Axmed’s unique ability to aggregate demand and leverage economies of scale, FCM will be offered at an exclusive access price for buyers purchasing through the Axmed platform. Institutional buyers can register for free on the Axmed platform, reinforcing Axmed’s commitment to expanding access to essential medicines in LMICs and ensuring that governments and impact-driven organizations can secure this life-saving treatment affordably and at scale.

Why This Matters
Iron deficiency anemia is a silent crisis, disproportionately impacting pregnant women and contributing to over 20% of maternal deaths in sub-Saharan Africa, as well as increasing the risks of preterm births and low birth weights. Alarmingly, more than 40% of pregnant women globally suffer from anemia, with the heaviest burden falling on LMICs. This partnership is a bold response to those staggering statistics—because no mother or newborn should have their futures stolen by preventable conditions.

A Vision for Healthier Futures
Driven by a shared purpose, Emcure and Axmed are committed to transforming Maternal, Newborn, and Child Health (MNCH). Together, they aim to ensure that high-quality, affordable solutions like FCM reach the communities that need them most.

At Axmed, we are powered by the belief that healthcare is a right, not a privilege,” said Emmanuel Akpakwu, CEO of Axmed. “This partnership with Emcure reflects the tangible impact we’re creating for underserved populations. By leveraging our innovative marketplace model, we’re bridging gaps that have too long hindered access to life-saving solutions. We envision a world where no mother or newborn is left behind.”

Collaboration for Systemic Change
The partnership goes beyond transactions – it represents a shared commitment to innovating for impact. Emcure’s expertise in producing high-quality FCM and Axmed’s unique procurement platform combine to tackle systemic barriers to healthcare delivery. FCM in particular stands as a cornerstone in MNCH, delivering life-saving impact where it’s needed most to reduce maternal and newborn mortality. Its significance transcends anemia, however, addressing diverse health needs in a wide spectrum of therapeutic areas, including gynecology, cardiology, blood related disorders, oncology, respiratory and HIV, underscoring its transformative potential across healthcare.

“At Emcure, we believe in the power of collaboration to unlock possibilities and transform lives,” said Satish Mehta, CEO and Managing Director, Emcure Pharmaceuticals. “This partnership with Axmed is a testament to what can be achieved when purpose and innovation align. Together, we’re advancing maternal and newborn health, demonstrating our commitment to affordable healthcare globally, and creating a ripple effect of positive change”

Turning Challenges into Opportunities
Maternal and newborn health is at a crossroads, and partnerships like this are catalysts for change. “FCM is more than a treatment—it’s a lifeline,” said Felix Ohnmacht, Chief Commercial Officer of Axmed. “Through our partnership, we’re not just aggregating demand; we’re amplifying hope and delivering impact where it’s needed most. By securing a unique access price on FCM for Axmed’s platform, we’re creating a unique opportunity for governments and organizations to access this life-saving solution affordably. Every mother saved and every newborn given a chance at life underscores why this work matters.”

About Emcure Pharmaceuticals
Emcure Pharmaceuticals Ltd. (EPL) is a leading Indian pharma company headquartered in Pune, India engaged in developing, manufacturing and globally marketing a broad range of pharmaceutical products. Known for its commitment to innovation, quality, and patient-centricity, Emcure is an R&D driven company that develops and manufactures a wide range of differentiated pharmaceutical products designed to improve patient health and well-being across several major therapeutic areas. Established in 1981, EPL is ranked as the 12th largest pharma company in India in terms of Domestic Sales for MAT June 2024. Emcure is present in 70+ countries globally including Europe and Canada.

About Axmed
Axmed is an innovative healthcare venture focused on transforming access to medicines across low- and middle-income countries (LMICs). Through its robust digital platform, Axmed operates a two-sided B2B marketplace that bridges the gap between pharmaceutical manufacturers/suppliers and healthcare providers, ensuring a steady, affordable supply of critical medicines. By leveraging technology, strategic partnerships, and a deep understanding of the unique challenges faced by LMICs, Axmed is committed to fostering sustainable health outcomes and accelerating global health equity.

Media contact:
Emcure media contact: naveen.soni@emcure.com
Axmed media contact: info@axmed.com

Innovating for Equity: Axmed Leads the Charge in Transforming Access to Medicines at Scale

Axmed’s transformative Medicines Platform and Access Summit create new pathways for equitable healthcare access for billions.
Nairobi, Kenya – February 6, 2025 – Axmed, a Health-tech social impact company, today introduced the Axmed Medicines Platform and unveiled its inaugural Axmed Access Summit in Nairobi. Anchored by the theme, “Unlocking Access, Transforming Lives,” the summit unites global leaders, changemakers, and innovators to address systemic barriers to healthcare and explore actionable strategies for meaningful change.

Redefining Healthcare Access for the Underserved

The Axmed Medicines Platform is reimagining how underserved health systems and their populations access life-saving medicines. By leveraging technology and an innovative business model, Axmed addresses deep-rooted inefficiencies in healthcare procurement that disproportionately affect low- and middle-income countries (LMICs).

According to the World Health Organization, over 80% of global population growth in the next decade will occur in LMICs—regions already carrying the heaviest disease burdens globally.

“These regions face extraordinary challenges but also present immense opportunities for healthcare transformation,” said Emmanuel Akpakwu, CEO of Axmed. “Our platform tackles these inequities by consolidating fragmented systems, empowering buyers with efficiency, high quality, and affordability, while enabling suppliers to scale sustainably in untapped markets.”

The platform is open to all qualified procurers and aggregates demand across healthcare providers, hospitals, and governments, creating unmatched purchasing power for buyers. For suppliers, it streamlines the procurement process and enhances transparency and reliability, ensuring medicines reach the communities that need them most.

More than 60 leading organizations spanning the entire medicines delivery value chain are actively engaging with Axmed to enhance access to high-quality medicines. These include global, regional and local pharmaceutical manufacturers, governments, major buyers, and a coalition of leading logistics companies.

Enhancing Maternal and Child Health While Expanding Healthcare Access

With funding from the Gates Foundation and venture backer Founderful, Axmed is driving systemic change to improve access to essential medicines for underserved populations. A key aspect of this work, supported by Axmed’s strong partnership with the Gates Foundation, centers on Maternal, Newborn, and Child Health (MNCH), aiming to reduce mortality rates in Kenya, Ethiopia, Tanzania, Rwanda, and Nigeria.

Hon. Cabinet Secretary Dr Deborah Barasa, of the Kenyan Ministry of Health, underscored the importance of family health, highlighting that “Maternal and newborn deaths represent some of the most profound challenges for families and for our nation as a whole.” Dr. Barasa further highlighted the transformative role of innovation-driven partnerships: “Prioritizing innovation across the healthcare value chain is critical to delivering medicines and care at scale, and it remains a key focus for our government. We strongly believe in partnerships that truly empower our country to serve more patients with greater efficiency and impact.”

At the same time, Founderful’s support enables Axmed to expand its mission to serve all patients across all therapeutic areas. Together, these partnerships empower Axmed to scale its innovative platform, strengthen healthcare systems, and deliver transformative solutions that ensure equitable access to life-saving care for patients everywhere. Axmed’s holistic approach reflects a shared commitment to building sustainable healthcare systems that advance equitable access to high-quality treatments for all.

Axmed Access Summit: A Catalyst for Action and Collaboration

While the Axmed Medicines Platform provides the infrastructure for scalable impact, the Axmed Access Summit is designed to inspire action and forge partnerships. Bringing together thought leaders from healthcare, technology, and policy, the summit aims to build actionable solutions to close access gaps.

“Why host a summit?” Akpakwu asked. “Because no technology can solve these challenges in isolation. True transformation depends on partnerships and shared accountability. The summit fosters collaboration and charts a clear path for collective impact.”

The summit encourages dialogue across the healthcare value chain, enabling participants to share insights, build alliances, and co-create solutions that deliver medicines sustainably and at scale.

Revolutionizing Procurement for a Greater Impact

Axmed’s model is uniquely tailored to the realities of LMIC markets, aligning the interests of buyers, suppliers, logistics providers, and enablers:

• For Buyers:

Through the Axmed Platform, governments, faith-based organizations, and NGOs have frequently achieved over 25% savings on pharmaceuticals and logistics, while gaining greater transparency and operational efficiency. These partners span a broad spectrum, including government entities such as Rwanda Medical Supply (RMS) and the Organization of Eastern Caribbean States (OECS) with its 9 national member states, numerous faith-based organizations (FBOs) such as Mission for Essential Drugs & Supplies (MEDS), The Christian Health Association of Nigeria (CHAN-Medipharm), Joint Medical Store Uganda (JMS), The Christian Health Association of Malawi (CHAM), the Ecumenical Pharmaceutical Network (EPN), and large hospital networks.

• For Suppliers:

The platform has engaged with pharmaceutical companies who share a similar vision of enhancing access to medicines in underserved markets. Global industry leaders, including Pfizer, Sanofi, GSK, Dr. Reddy’s Laboratories, and others, are joined by local innovators like Dawa Life Sciences, Laboratory & Allied, Regal Pharmaceuticals, Cosmos Pharmaceuticals, Emzor, and Fidson, in their ongoing engagement to support the building of a robust, efficient and scalable platform for the benefit of LMIC markets.

• For Logistics Providers:

Reliable, tech-enabled distribution networks such as Kuehne + Nagel, Scan Global Logistics, CEVA Logistics, and Allied Logistics (formerly Agility), among others, and crucial local partners ensure that medicines reach even the most remote and resource-constrained areas.

• For Enablers:

Strategic partnerships – including a grant from the Gates Foundation – are amplifying systemic change. These collaborations enable Axmed to strengthen healthcare systems, improve access to essential medicines, and drive transformative impact in underserved communities.

Transforming Systems Through Transparency and Efficiency

Axmed sets a new standard for transparency and efficiency in healthcare procurement. By consolidating demand and optimizing supply chains, the platform delivers significant cost savings on both pharmaceuticals and logistics, maximizing value for all stakeholders.

“Our success isn’t just about lowering costs; it’s about improving lives and strengthening healthcare systems,” Akpakwu explained. “The Axmed platform and summit represent pivotal steps toward healthcare equity, but we know the journey doesn’t end here. We’re committed to scaling this vision alongside partners who share our mission.”

About Axmed

Axmed is a pioneering, technology-driven healthcare platform dedicated to transforming access to essential medicines in low- and middle-income countries. Through innovation and strategic partnerships, Axmed addresses systemic inefficiencies, optimizes supply chains, and empowers stakeholders to deliver high-quality medicines where they are needed most.

From Crisis to Opportunity: Transforming Access to Medicines for the 21st Century

At Axmed, we are committed to reshaping the landscape of global healthcare, ensuring that access to life-saving medicines becomes a reality for all. Our CEO, Emmanuel Akpakwu, recently penned a thought-provoking article on this very topic, which has been syndicated across major outlets in Kenya, sparking important conversations about the future of healthcare access.

In the article, titled “From Crisis to Opportunity: Transforming Access to Medicines for the 21st Century,” Emmanuel delves into how bold, innovative actions can address the systemic challenges in global health. He outlines the transformative potential of partnerships, technology, and community-driven solutions to overcome barriers in equitable healthcare delivery.

We are proud to highlight that this article has garnered widespread attention and was featured prominently on Capital FM Kenya’s business platform:

The insights shared in the piece were also picked up by other leading publications, reflecting the resonance of this message across audiences:

The central theme of Emmanuel’s article resonates deeply with our mission at Axmed: to challenge the status quo and redefine what is possible in healthcare access. We believe that by fostering collaboration, leveraging innovative technologies like the Axmed Platform, and empowering communities, we can turn today’s global health crises into opportunities for impactful change.

We encourage you to explore the article and join us in the conversation about building a healthier, more equitable future.

Let’s keep transforming healthcare, together.

About Axmed: Axmed is a tech-driven B2B platform revolutionizing access to medicines across Sub-Saharan Africa. Through innovative partnerships and technology, we’re streamlining procurement and ensuring cost-effective delivery of essential medicines to underserved communities.

Axmed Partners to Transform Maternal Healthcare in Africa

Breaking Barriers to MNCH Access: A Transformative Partnership

At Axmed, we’re proud to announce a groundbreaking partnership aimed at improving access to life-saving medicines for mothers, newborns, and children (MNCH). Together with the Mission for Essential Drugs and Supplies (MEDS) in Kenya and CHAN Medi-Pharm in Nigeria, as well as Ecumenical Pharmaceutical Network (EPN), we are tackling critical barriers in global health, driven by a shared vision to ensure equitable healthcare access for all.

Every year, preventable pregnancy and childbirth complications claim the lives of over 287,000 women, while 2.3 million newborns die within their first month. These staggering figures underscore the urgent need for bold, innovative solutions that challenge the status quo.

Emmanuel Akpakwu, Chief Executive Officer of Axmed, highlighted:

“Collaboration is the cornerstone of transformative healthcare solutions. This partnership exemplifies how we can break barriers to access and deliver life-saving medicines to the mothers and children who need them most. Together, we’re improving health outcomes for families across the continent.”

Driving Impact in Kenya and Nigeria

This collaboration focuses on scaling MNCH and nutrition interventions in underserved communities, with a commitment to empowering health workers and strengthening healthcare systems. By leveraging faith-based organizations’ deep-rooted connections in these communities, we aim to align care with national guidelines and drive sustainable solutions—such as drug revolving funds—across 250 health facilities in Kenya and Nigeria.

The Axmed Platform plays a pivotal role in this effort, streamlining procurement and ensuring cost-effective access to essential medicines for postpartum hemorrhage and neonatal care. These efforts are already delivering measurable impact, with thousands of families benefiting from improved access to care.

Richard Neci, Executive Director at EPN, emphasized:
“Faith-based organizations play a crucial role in underserved communities. By expanding this partnership, we’re building stronger healthcare systems and ensuring no family is left behind. We believe we can scale this across the continent.”

Wycliffe Nandama, Managing Director of MEDS, remarked:
“Axmed’s initiative is fully aligned with MEDS’ vision of providing transformative health solutions globally.”

Olusanya Ezekiel Omirin, Acting Managing Director of CHAN Medi-Pharm Limited/Gte, stated:
“CHAN Medi-Pharm Limited/Gte is happy to collaborate with Axmed in working towards increasing access to affordable medicines and healthcare commodities for all patients in Nigeria. We are confident this partnership will result in significant cost savings and improve access to quality medicines in Nigeria.”

Felix Ohnmacht, Chief Commercial Officer at Axmed, shared:
“This partnership is built on the belief that innovation and collaboration can transform healthcare access. By leveraging in-country expertise and the power of technology, we’re addressing some of the toughest challenges in maternal and child health. We’re guided by an unwavering belief in the value of every human life and together, we’re creating a future where quality care is accessible to everyone.”

A Bold Vision for the Future

With the open release of the Axmed Platform on January 30, 2025, and the Access Summit on February 6, 2025, we are taking the next step in our mission to revolutionize healthcare access. This partnership is just the beginning of a bold journey to transform health outcomes for families across Sub-Saharan Africa.
We invite all who share our vision of equitable healthcare to join us. Together, we can build a future where no mother or child is left behind. Stay tuned for more updates as we advance this vital work.

Axmed Wins Prestigious Norrsken Impact/100 Award, Spotlighted at Times Square

Axmed, the groundbreaking B2B marketplace revolutionizing access to essential medicines, has been honored as a 2024 Norrsken Impact/100 startup. This esteemed recognition highlights Axmed as one of the most promising impact-driven companies globally, underscoring its commitment to ensuring life-saving medicines reach those in need, regardless of location.

Global Recognition During New York Climate Week

As part of the celebration, Axmed’s logo was prominently displayed on the iconic Nasdaq Tower in Times Square during New York Climate Week 2024. This visibility symbolizes Axmed’s dedication to advancing healthcare equity in underserved regions and its place among a range of global companies providing “100 ways to fix the future.”

A Beacon of Hope in Global Health

Emmanuel Akpakwu, CEO of Axmed, expressed gratitude for the recognition: “Norrsken created the Impact/100 to inspire hope and positive change. We’re honored to be part of this movement and remain committed to transforming healthcare by making critical medicines accessible, especially in low- and middle-income countries.”

Pioneering HealthTech Solutions

As an emerging leader in HealthTech, Axmed joins an elite group of startups addressing pressing global challenges in line with the UN’s sustainable development goals. The Norrsken Impact/100 spotlights these innovative companies, emphasizing their potential for creating lasting, global impact.

Looking Ahead: Expanding Access and Partnerships

Bolstered by this award, Axmed is poised for its next growth phase:
– Enhancing its marketplace platform
– Expanding strategic partnerships
– Ensuring equitable access to essential medicines across communities

About Axmed

Axmed is transforming healthcare access in LMICs through its innovative B2B marketplace. By bridging the gap between healthcare providers and pharmaceutical manufacturers, Axmed is driving more equitable healthcare solutions worldwide.

Contact Information
Axmed
Media Contact: Katie Clift
Phone: +351 913 976 202
Email: katie@maybe.agency
Website: https://www.axmed.com

Poor countries desperately need better access to generic medicines

Manufacturers showed during the pandemic that they can deliver low-cost treatments at scale.

The Covid-19 pandemic underscored the urgent need for equitable access to medicine. But when it comes to expanding access, the pivotal role of the world’s generic medicine manufacturers often slips under the radar. This is despite the fact that the global market was worth $311.8bn in 2022, and is projected to hit $442.3bn by 2027.

It is often assumed that generic drugs are affordable and widely available to those who need them. But this is not entirely true. For example, even after patent expiries open the door to generic rivals, low levels of competition between companies in smaller markets means that generics can actually be more expensive in poor countries than in wealthy ones.

Many essential generic medicines are also often absent from pharmacy shelves in poorer countries, particularly in rural and remote areas — frequently with devastating results.

Today, generics are a cornerstone of health systems. Ninety per cent of the medicines included on the World Health Organization’s Model List of Essential Medicines are off-patent, meaning companies can make their own versions of these key products.

The huge footprint of the sector gives it a correspondingly huge importance in addressing the issues that leave millions of people worldwide without access to the treatments they need. Generics companies must now make a conscious effort to address global health challenges and realise their potential as key players in access to medicine.

We know this is possible, because generics companies are already experts at delivering lower-cost treatments at scale, and have stepped up previously to address urgent issues. Early in the Covid pandemic, for example, manufacturers leveraged their production capacity to respond rapidly, ensuring that many existing medicines remained available despite global supply chain disruptions.

Such efforts undoubtedly saved many lives — but they remain exceptional. To remedy this, the Access to Medicine Foundation has developed a new analytical framework to guide generic medicine manufacturers in converting exceptions into the rule. Initially, the framework will be used to assess the efforts of five companies: Cipla, Hikma, Sun Pharma, Teva and Viatris.

We are at an important moment in the generics industry’s development, as there are many opportunities for companies to seize, from working with local manufacturers to improve supply in low- and middle-income countries, to investing in adaptive research and development.

There are also more opportunities to engage in licensing agreements, through which the big pharmaceutical groups allow generics companies to launch versions of their on-patent medicines. With Big Pharma increasingly issuing these licences, including the first covering a cancer drug, generics companies have both a business opportunity and a chance to expand patients’ access to innovative medicines.

There are further opportunities in the market for biosimilars — copies of biological drugs — with their global market value projected to rise to $60.8bn in 2027. Biosimilar medicines first arrived on the scene over a decade ago, but the market has recently gained momentum with the expiry of patents on blockbuster biological drugs and with the WHO’s expansion of its prequalification assessment scheme to include a number of biosimilars. Although these drugs have yet to make significant inroads in low and middle-income countries compared with high-income ones, they offer great potential if access barriers can be broken down.

Generic medicine manufacturers have a central role to play in expanding access to medicine. Now is the time for them to explore the opportunities that will ensure people around the world gain access to the medicines they need.

FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment

FDA NEWS RELEASE

Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain—including amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections. These changes affect a person’s ability to remember and think.

Leqembi was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The results of a Phase 3 randomized, controlled clinical trial to confirm the drug’s clinical benefit have recently been reported and the agency anticipates receiving the data soon.

Researchers evaluated Leqembi’s efficacy in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer’s disease. Treatment was initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology. Patients receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, with patients receiving the approved dose of lecanemab, 10 milligram/kilogram every two weeks, having a statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque.

These results support the accelerated approval of Leqembi, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer’s disease. Amyloid beta plaque was quantified using positron emission tomography (PET) imaging to estimate the brain levels of amyloid beta plaque in a composite of brain regions expected to be widely affected by Alzheimer’s disease pathology compared to a brain region expected to be spared of such pathology.

The prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities (ARIA), which are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur. ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure. Another warning for Leqembi is for a risk of infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure. The most common side effects of Leqembi were infusion-related reactions, headache and ARIA.

As specified in the prescribing information, Leqembi is indicated for the treatment of Alzheimer’s disease. The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials. The labeling also states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

The FDA granted this application Fast TrackPriority Review and Breakthrough Therapy designations.

The approval of Leqembi was granted to Eisai R&D Management Co., Ltd.

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Corona virus hits america again

Pharmaceutical companies invest heavily in R&D in order to discover and develop new drugs that can be brought to market. The R&D process can be very expensive and time-consuming, often taking many years and requiring significant investment in clinical trials, regulatory compliance, and marketing. As a result, the cost of developing a new drug can run into billions of dollars.

Drug shortages worsen in South Africa: In February 2021, it was reported that drug shortages in South Africa had worsened due to the COVID-19 pandemic

In February 2021, it was reported that drug shortages in South Africa had worsened due to a combination of factors, including the COVID-19 pandemic, a lack of investment in local manufacturing, and regulatory delays.

The shortages have affected both essential medicines and drugs used to treat COVID-19. For example, some hospitals were reportedly running out of oxygen supplies, while others were experiencing shortages of painkillers, antibiotics, and other critical drugs. The situation was particularly acute in rural areas and townships, where healthcare infrastructure is often under-resourced and overburdened.

According to the South African Health Products Regulatory Authority, the COVID-19 pandemic has disrupted global supply chains and led to shortages of raw materials, which has in turn affected the production and distribution of medicines. In addition, the agency noted that there has been a lack of investment in local manufacturing, which has made the country more dependent on imports.

The regulatory delays have also been a factor in the drug shortages. For example, some pharmaceutical companies have faced delays in getting approval for their products, which has led to supply chain disruptions and shortages.

The South African government has acknowledged the severity of the drug shortages and has taken steps to address the problem. In March 2021, President Cyril Ramaphosa announced a plan to invest in local pharmaceutical manufacturing, with the aim of reducing the country’s reliance on imports. The government has also established a task force to address the drug shortages and ensure that essential medicines are available to those who need them.

Overall, the drug shortages in South Africa have highlighted the need for greater investment in healthcare infrastructure and local manufacturing, as well as more effective regulatory processes to ensure that essential medicines are available to all who need them.