The product’s rollout follows its regulatory approval in Ghana in February 2025, and a subsequent endorsement by Swissmedic in July, marking a breakthrough for malaria care in vulnerable populations. Developed through a partnership between Novartis and Medicines for Malaria Venture (MMV), Coartem Baby bridges a long-standing treatment gap for infants weighing less than 4.5 kg — a group previously left without a safe, approved malaria therapy.
Before this innovation, caregivers and health workers had to administer modified doses of treatments meant for older children. This practice often led to overdosing — with risks of toxicity — or underdosing, which could cause treatment failure and prolong illness.
“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 medicine’s efficacy and safety were confirmed through the CALINA Phase 2/3 clinical trial, carried out across several African nations by the PAMAfrica consortium, co-funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Swedish International Development Cooperation Agency (SIDA).
Led by Dr. Bérenger Kaboré of the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso, the CALINA study not only demonstrated strong scientific results but also highlighted the overlooked burden of malaria in infants under six months old. Local researchers, working closely with their communities, helped dispel the misconception that newborns are largely unaffected by malaria and built vital trust that enabled safe and ethical clinical data collection.
Ghana’s milestone aligns with its ongoing progress under the WHO’s High Burden to High Impact initiative, which has seen the country record notable declines in malaria incidence and mortality between 2017 and 2023.
Across Africa, roughly 30 million babies are born each year in areas at risk of malaria transmission. Surveys across West Africa have reported infection rates in infants under six months ranging from 3.4% to as high as 18.4%, underscoring the urgent need for interventions like Coartem Baby.
Novartis has pledged to make the treatment available on a largely not-for-profit basis, reinforcing its commitment to equitable access and the fight against one of Africa’s most persistent childhood killers.