In early July 2025, the Swiss agency for therapeutic products, Swissmedic, approved the first malaria treatment specifically designed for infants and very young children aged 2 months to 5 years. This groundbreaking development marks a significant advancement in the fight against malaria in Africa, where the disease disproportionately affects the youngest and most vulnerable populations. Previously, infants received medications formulated for older children, which were often not suitable for their unique physiological needs.
In an interview with The Conversation Africa, biochemist Fortunate Mokoena highlighted the importance of this approval, stating that the new drug represents a “shining milestone” in the journey to eradicate malaria. The World Health Organization (WHO) aims to end malaria by 2030, a goal that requires innovative approaches, including effective treatments tailored for children under one year old and weighing as little as 4.5 kg.
Mokoena emphasized that each step forward not only saves lives but also strengthens the resolve to create a malaria-free Africa, allowing every child to grow, thrive, and dream without the shadow of this disease. The potential economic impact is also significant, with eliminating malaria projected to save countless lives and unlock an estimated $126 billion in Africa’s GDP.
Current Malaria Landscape in Africa
Malaria remains one of Africa’s most pressing health challenges. In 2023, there were an estimated 263 million malaria cases and 597,000 deaths reported across 83 countries, with a majority among young children and pregnant women. The WHO African Region accounted for 94% of malaria cases and 95% of malaria deaths globally, with children under five representing approximately 76% of those fatalities.
The burden of malaria is heaviest in sub-Saharan Africa, especially in rural areas where poverty and limited access to healthcare exacerbate the situation. Addressing malaria presents a critical opportunity not only to save lives but also to unlock the potential of Africa’s children and promote healthier, more prosperous communities.
The Need for Tailored Treatments
Prior to the approval of this new drug, the lack of effective malaria treatment options specifically designed for neonates created a significant gap in care. Infants were often treated with medications intended for older children, which could lead to adverse effects and inadequate care. The physiological differences between children and adults necessitate a more personalized approach to treatment.
Mokoena noted that neonates are still developing their liver function, impacting how they metabolize medications compared to older infants. This underscores the urgent need for tailored treatment strategies in combating neonatal malaria.
The new drug, named Coartem Baby, was developed by Novartis in collaboration with the Medicines for Malaria Venture and co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The not-for-profit treatment aims to address the urgent need for effective malaria solutions as approximately 30 million children are born annually in malaria-risk areas across Africa.
Challenges Ahead and Future Outlook
While the approval of Coartem Baby is a significant step forward, challenges remain in the rollout of the drug. Swissmedic is collaborating with eight African countries to enhance distribution through a global health initiative. The drug has already been introduced in Ghana, with approvals expected soon in Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda.
Additional funding is essential for successful implementation, and leveraging local expertise can further improve outcomes. In some areas, formulations may require lyophilization to withstand conditions such as power cuts, presenting an additional hurdle.
Investing in local manufacturing infrastructure is crucial to reduce production costs and ensure the sustainability of malaria treatment in Africa. Mokoena’s research is supported by the Science for Africa Foundation and the Bill and Melinda Gates Foundation, highlighting the collaborative effort needed to combat this enduring disease.
As Africa’s drug discovery ecosystem continues to evolve, it holds promise for the future. The work of pioneers like Professor Kelly Chibale, whose groundbreaking antimalarial drug has reached Phase II clinical trials, showcases the continent’s potential to innovate and address health challenges.
The approval of Coartem Baby can serve as a catalyst, inspiring and empowering African scientists to keep building a pipeline of life-saving medicines. With growing expertise and determination, Africa is not only positioned to treat malaria but also to work towards its eradication, paving the way for a healthier and more prosperous future.
