Ghana became the first malaria endemic country to launch Coartem Baby, the first malaria treatment specifically designed and approved for young infants, during a ceremony in Accra on October 7, 2025.
Developed by Novartis in collaboration with Medicines for Malaria Venture (MMV), Coartem Baby closes a critical treatment gap for newborns and young infants. Until now, infants under 4.5 kilograms had no approved malaria treatment and were either administered formulations intended for older children, increasing the risk of overdose and toxicity, or underdose, increasing the risk of treatment failure.
The launch followed regulatory approval in Ghana in February 2025 and by Swissmedic, Switzerland’s therapeutic products agency, in July 2025. Malaria remains one of the deadliest diseases for children under five years old, claiming nearly 600,000 lives annually worldwide, with children accounting for almost three quarters of those deaths.
Dr. Martin Fitchet, chief executive officer (CEO) of MMV, stated that Ghana’s leadership in approving Coartem Baby represents a powerful step toward protecting the most vulnerable. The approval provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients.
Vas Narasimhan, CEO of Novartis, said the company has stayed the course in the fight against malaria for more than three decades, working relentlessly to deliver scientific breakthroughs where they are needed most. The pharmaceutical company developed the first clinically proven malaria treatment for newborns and young babies in partnership with MMV.
Coartem Baby uses artemether lumefantrine, the same compound found in standard Coartem but formulated specifically for infants and neonates weighing between 2 and less than 5 kilograms. The treatment addresses acute, uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum.
The Swissmedic approval was based on the Phase II/III CALINA study, which investigated a new ratio and dose of artemether lumefantrine to account for metabolic differences in babies under 5 kilograms. The drug is marketed as Coartem Baby in some countries and Riamet Baby in others.
Eight African countries participated in Swissmedic’s Marketing Authorization for Global Health Products (MAGHP) procedure for Coartem Baby and are expected to approve the medicine rapidly. The countries are Burkina Faso, Cote d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda. These eight countries accounted for 47 percent of estimated malaria cases in 2023 according to the World Health Organization (WHO).
Novartis has committed to introducing Coartem Baby on a largely not for profit basis to increase access in areas where malaria is endemic. More than 500 million Coartem Dispersible tablets, a cherry flavored artemisinin based combination therapy for children over 5 kilograms, have been distributed worldwide since launching in 2009.
The MAGHP process provides a trusted shortcut to approval for low and middle income countries that have limited regulatory capacity. Countries participating in the assessment are expected to proceed with registering and approving the medicine through their national regulatory agencies within 90 days.
MMV is a Swiss based not for profit organization initially backed by the British, Swiss and Dutch governments, along with the World Bank and the Rockefeller Foundation. The organization works to develop antimalarial medicines and expand access to treatment in endemic countries.
Caradise Ghana, a chauffeur driven car and bus rental company based in Accra, provided transportation services for executives and researchers from MMV and Novartis during the four day launch event. Alkistis Evangelidou, events manager for MMV, praised the company’s professionalism and attention to detail in handling airport pickups, hotel transfers and transport arrangements.
The launch coincides with ongoing malaria prevention efforts in Ghana and other African countries. Health clinics administer RTS,S or R21 malaria vaccines to children between 6 and 24 months old, though these vaccines reduce infection chances by only 40 percent. Coartem Baby can address breakthrough infections that occur despite vaccination.
Seasonal malaria chemoprevention (SMC) involves giving young children courses of antimalarial medicine during the rainy season when infections reach peak levels. This strategy maintains drug levels in children’s blood, providing protection during high risk periods.
Countries including Democratic Republic of Congo, Ghana, Kenya and Malawi have rolled out malaria vaccinations in recent years. The introduction of Coartem Baby provides an additional tool in the antimalarial arsenal for treating the youngest and most vulnerable patients.
