Breakthrough Malaria Drug For Newborns Gains Approval, Set For Rapid Rollout In Africa

 

A new malaria treatment specifically designed for newborns and young infants has received regulatory approval and is poised for rapid distribution across several African nations, according to pharmaceutical company Novartis.

The medication, marketed as Coartem Baby or Riamet Baby in some countries, has been approved by Swiss authorities for use in infants weighing between 2 and 5 kilograms (4.4 to 11 pounds). Formulated for easier administration to newborns, the drug offers a crucial treatment option for one of the most vulnerable groups affected by malaria.

While Coartem Baby is already approved in Ghana, Novartis expects eight additional African countries — Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda — to approve the drug within 90 days. All of these nations participated in the assessment process.

“This is the first clinically proven malaria treatment designed specifically for newborns and young babies,” said Novartis CEO Vas Narasimhan. “It ensures even the smallest and most vulnerable can finally receive the care they deserve.”

Until now, infants under six months old have often been treated with antimalarials intended for older children, raising the risk of overdose or toxicity due to improper dosing. The new formulation provides a safer, targeted solution for this overlooked patient population.

In 2023, malaria caused 263 million infections and 597,000 deaths globally — nearly all of them in Africa, according to the World Health Organization. Children under 5 made up around 75% of those deaths.

The drug was developed in partnership with the Medicines for Malaria Venture (MMV), a Swiss nonprofit dedicated to fighting the disease. Novartis says it plans to distribute Coartem Baby in the coming weeks on a largely not-for-profit basis.

“Malaria remains one of the world’s most lethal diseases, especially for children,” said MMV CEO Martin Fitchet. “The approval of Coartem Baby gives healthcare providers a vital, optimized tool to treat infants who have long been left without appropriate options.”

The rollout marks a significant advancement in the global fight against malaria and is expected to play a key role in reducing infant mortality from the disease across sub-Saharan Africa.