Novartis Secures Approval for First-Ever Malaria Treatment Designed for Newborns After a Decade of Research

Swiss pharmaceutical company Novartis has announced that its pediatric formulation Coartem Baby (artemether-lumefantrine) has received regulatory approval from Swissmedic, the Swiss Agency for Therapeutic Products. The treatment, designed specifically for newborns and infants weighing under 4.5 kilograms, marks the world’s first malaria therapy tailored for this highly vulnerable population.

Over 30 Million Newborns at Risk Annually with No Prior Approved Malaria Treatment for Infants

Coartem Baby is a result of over a decade of research and development by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a non-profit focused on fighting malaria through innovative drug development. The approval is expected to pave the way for expedited regulatory access in malaria-endemic countries under Swissmedic’s “Marketing Authorization for Global Health Products” framework. Novartis emphasized its commitment to equitable access by stating that Coartem Baby will be supplied to high-risk regions using an “at-cost or non-profit model.”

Each year, over 30 million newborns are born in areas where malaria transmission is active. Until now, no malaria treatment had been specifically developed and approved for neonates. According to data from West Africa, malaria infection rates among infants under six months can range from 3.4% to 18.4%.

Concerns about infants’ underdeveloped liver function and differing metabolic profiles have often led researchers to exclude them from clinical trials despite these risks. Consequently, medical practitioners have frequently had to administer reduced doses of treatments designed for older children.

“The available malaria treatments have only been properly tested in children aged at least 6 months because smaller infants are usually excluded from treatment trials,” said Professor Umberto D’Alessandro, Director of the MRC Unit, The Gambia at the London School of Hygiene and Tropical Medicine. “That matters because neonates and young infants have immature liver function and metabolize some medicines differently, so the dose for older children may not be appropriate for small babies.”

A Formulation Tailored to the Needs of Newborns

Coartem Baby introduces a thoughtfully developed formulation tailored specifically for the youngest patients. It features a cherry-flavored, dispersible tablet that dissolves easily in breast milk or clean drinking water. This not only simplifies administration but also improves the treatment experience for infants who may otherwise resist medication.

Researchers have calibrated the dosing to ensure both safety and efficacy for infants under 4.5 kg, addressing longstanding concerns about toxicity and underdosing in this age group. Novartis led the formulation efforts, with support from MMV and funding through the PAMAfrica consortium. The European & Developing Countries Clinical Trials Partnership (EDCTP) and the Swedish International Development Cooperation Agency (Sida) fund the collaborative initiative PAMAfrica.

To ensure rapid access to Coartem Baby in high-burden regions, eight African countries are participating in a joint regulatory review led by Swissmedic. This initiative streamlines approval processes across participating nations, significantly reducing the time needed for local market authorization. Once authorities approve Coartem Baby, they can quickly distribute it to national health systems, strengthening pediatric care infrastructure in malaria-endemic zones.

Author

Denisse Sandoval

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