Novartis has announced that it has received approval in Switzerland for Coartem® Baby—the first approved malaria treatment specifically developed for babies and young children. This milestone paves the way for accelerated approvals in eight African countries that participated in the joint regulatory assessment.
Also marketed as Riamet® Baby in select markets, the formulation addresses a long-standing treatment gap for infants weighing less than 4.5 kilograms, a group previously without an approved malaria therapy.
Originally launched in 1999, Coartem is a well-established anti-malarial. The new infant formulation features a lower-dose strength tailored for babies and is dissolvable in liquids—including breast milk. With a cherry flavour, it is designed for easier administration and greater compliance among caregivers.
“Until now, there has been no approved malaria treatment for infants under 4.5kg. This approval marks a breakthrough in expanding equitable access to life-saving interventions,” Novartis stated.
The African countries involved in the assessment—Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda—are expected to fast-track local authorisations, supported by the collaborative review under the African Medicines Regulatory Harmonization initiative.
Each year, over 30 million babies are born in regions at risk of malaria across Africa. According to Novartis, infection rates among infants under six months can range from 3.4% to 18.4%, based on data from a regional survey in West Africa.
This latest development reinforces Novartis’ long-term commitment to malaria elimination, particularly among the most vulnerable populations. With infant malaria still a significant driver of child mortality in sub-Saharan Africa, the introduction of Coartem Baby is expected to close critical gaps in early-life treatment and improve survival outcomes.
The company continues to work alongside global health partners and African governments to scale access to the new treatment across high-burden settings.
