Coartem® Baby launches in Ghana
Today, Ghana became the first malaria-endemic country to launch Coartem® (artemether-lumefantrine) Baby, the first malaria treatment specifically designed and approved for young infants. This follows its regulatory approval in Ghana in February 2025 and by Swissmedic in July.
Developed by Novartis in collaboration with MMV, Coartem Baby closes a critical treatment gap for the youngest and most vulnerable patients. Until now, infants under 4.5 kg 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.
“Malaria remains one of the deadliest diseases for children under five years old, and Ghana’s leadership in approving Coartem Baby is a powerful step toward protecting the most vulnerable,” said Dr Martin Fitchet, CEO of MMV. “This optimized formulation offers a well-tolerated and effective solution to a long-standing unmet medical need.”
The CALINA Phase 2/3 clinical trial, conducted across several African countries, demonstrated that Coartem Baby was both well-tolerated and efficacious in infants under 5 kg. It was implemented by the PAMAfrica consortium, co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.
Led by Dr Bérenger Kaboré, from the Clinical Research Unit of Nanoro (CRUN), Burkina Faso, the CALINA study also enabled key researchers in high malaria-burden countries to demonstrate the extent of the unmet need within their communities. Their work challenged and countered long-held assumptions that malaria has minimal impact on infants. Through their pivotal role in building trust within their communities through outreach and education, they were instrumental in safely and equitably generating the data to close this evidence gap for health impact for their communities.
Ghana is one of 11 African countries designated by WHO as High Burden to High Impact, showing progress in reducing incidence and mortality rates from 2017–2023.
There are about 30 million babies born in areas of malaria risk in Africa every year, with one large survey across West Africa reporting infections in babies under 6 months old ranging from 3.4% to as high as 18.4%.1
Novartis has committed to introducing Coartem Baby on a largely not-for-profit basis.
1. Ceesay SJ et al. Malaria Prevalence among Young Infants in Different Transmission Settings, Africa. Emerg Infect Dis. 2015 Jul;21(7):1114-21. doi: 10.3201/eid2107.142036. PMID: 26079062; PMCID: PMC4480393.