Coartem Baby to close treatment gap for Africa’s youngest patients
Novartis announced on Tuesday it has received regulatory approval in Switzerland for Coartem Baby, the first-ever malaria treatment specifically formulated for newborns and very young children. The new drug addresses a long-standing gap in care for infants under 4.5 kilograms, who until now had no approved malaria therapy available.
Co-developed with support from the non-profit Medicines for Malaria Venture (MMV), the formulation is designed to dissolve easily — even in breast milk — and features a cherry flavor to ease administration for babies. Novartis noted that previous treatments were only tested in children six months and older, forcing physicians to adapt adult or child doses for newborns, risking overdoses.
Eight African nations to follow with fast-track approvals
In parallel with the Swiss approval, eight African countries that participated in the regulatory assessment — Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda — are now expected to issue local approvals quickly. These countries represent some of the hardest-hit regions by malaria, where the lack of tailored treatment options for infants has had deadly consequences.
Each year, approximately 30 million babies are born in malaria-risk zones across Africa. Novartis cited a recent West African survey showing infection rates in infants under six months ranging from 3.4% to 18.4%. Malaria vaccines currently on the market are also not approved for the youngest babies, making pharmaceutical intervention critical.
Affordable rollout, major public health milestone
Coartem Baby, also marketed as Riamet Baby in some regions, will be distributed on a largely not-for-profit basis. The launch reflects Novartis’ long-standing role in malaria treatment innovation, dating back to its release of the original Coartem in 1999. The new infant formulation represents an evolution of that commitment, with dosing calibrated specifically for the body weight and needs of the youngest patients.
“Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve,” said Novartis CEO Vas Narasimhan.