Zurich: Swiss pharmaceutical giant Novartis announced that it has received regulatory approval in Switzerland for Coartem Baby, the world’s first approved malaria treatment specifically designed for newborns and young children.
The new formulation addresses a critical treatment gap for infants weighing less than 4.5 kilograms who, until now, had no approved medication for malaria. The approval paves the way for swift regulatory clearance in eight African countries that participated in the joint assessment of the drug, Novartis said.
These countries, Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda, are expected to issue approvals soon, enabling faster access to the lifesaving medicine across regions hardest hit by malaria.
Coartem Baby, also known in some markets as Riamet Baby, is a pediatric adaptation of Coartem, the malaria treatment Novartis first introduced in 1999.
The new formulation comes in a smaller dose specifically for small babies and is designed to be easily administered: it is dissolvable, including in breast milk, and has a sweet cherry flavor to help ensure better compliance in infants.
Novartis receives approval for first malaria medicine for newborn babies and young infants. https://t.co/8YiwBghRB6 #NovartisNews
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“Until now, infants weighing less than 4.5 kilograms have had no approved treatment options for malaria, leaving a dangerous gap in care,” Novartis said in a statement.
Each year, approximately 30 million babies are born in malaria-endemic regions across Africa, where the risk of infection is high. Novartis cited a recent survey across West Africa showing malaria infection rates in infants under six months ranging from 3.4 percent to 18.4 percent.
Malaria remains one of the deadliest diseases in sub-Saharan Africa, with young children and babies particularly vulnerable. The availability of a dedicated treatment for this age group is seen as a crucial step in reducing malaria-related deaths and complications.
The eight participating African countries, all of which are among the most affected by malaria, are expected to fast-track national approvals for Coartem Baby following Switzerland’s regulatory green light.
