It’s a sobering truth: malaria still claims the lives of hundreds of thousands of children every year, with the youngest being most at risk. Until now, doctors treating newborns and very small infants under 5 kg faced a dilemma – no treatment had ever been designed specifically for them. Instead, fragile babies received scaled-down doses of standard medication, a workaround that raised concerns about safety and effectiveness.
But that gap in care has just been filled. On 8 July 2025, Swissmedic approved Coartem® Baby (artemether-lumefantrine), the first-ever malaria treatment made for babies and young infants. Developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), the treatment marks an important advance in global health.
Why This Approval Matters
Every year, around 75% of malaria deaths occur in children under five. For the smallest of them – those weighing less than 5 kg – treatment has always been a challenge. Their immature metabolism made traditional dosing risky, leaving a critical gap in life-saving care.
With Coartem® Baby, that changes. The dispersible formulation was designed specifically for this age and weight group, offering a safe and effective option that didn’t exist before.
The CALINA Study
The approval follows the success of the CALINA trial, part of the EDCTP2-funded PAMAfrica project. Conducted by researchers in Burkina Faso, the Democratic Republic of the Congo, Kenya, Mali, Nigeria, and Zambia, across eight African countries, the trial tested the new baby-friendly formulation in real-world settings.
The findings? The drug achieved the right bloodstream levels to clear malaria parasites, comparable to what has been proven effective in older children, while also generating important new safety data. In short: it works, and it’s safe.
A Global Partnership
This development is the result of a global partnership: Novartis, MMV, African and European research institutions, and funding support from the Swedish International Development Cooperation Agency (Sida). Together, they built a solution that directly addresses the needs of malaria-endemic regions.
Dr Montserrat Blázquez-Domingo of the EDCTP Association praised the achievement, calling it “a much-needed, effective treatment for young children suffering from malaria shortly after birth.”
The Next Steps
Thanks to Swissmedic’s Marketing Authorization for Global Health Products pathway, countries that took part in the trial are expected to fast-track local approvals. Even better, Novartis has stated they intend to make Coartem® Baby available largely on a not-for-profit basis, ensuring access where it’s needed most.
For families, health workers, and communities battling malaria every day, this isn’t just a regulatory update. It’s hope, packaged in a small, infant-friendly dose.
