Novartis malaria treatment Coartem® Baby receives WHO prequalification
April 26, 2026 | Sunday | News
Coartem® (artemether-lumefantrine) Baby is the first and only malaria treatment for newborns and young infants
Novartis has announced that the World Health Organization (WHO) has prequalified Coartem® (artemether-lumefantrine) Baby, the first and only antimalarial developed specifically for newborns and young infants weighing from 2 to 5 kilograms.
The decision is a key step towards enabling widespread access through public sector procurement. Coartem Baby is also known as Riamet® Baby in some countries and was developed in collaboration with Medicines for Malaria Venture (MMV).
“This new formulation of artemether-lumefantrine represents an innovation as there are no antimalarial medicines specifically developed for the treatment of uncomplicated malaria in children from 2 to 5 kilograms body weight,” said Dr Daniel Ngamije Madandi, Director, Malaria and Neglected Tropical Diseases at the WHO.
Novartis is making the treatment available on largely not-for-profit basis in malaria-endemic regions.
Until recently, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, leaving a treatment gap. The smallest infants with malaria have instead been treated with formulations intended for use in older children, which may increase the risk of side effects and toxicity.
Coartem Baby was developed by Novartis with the scientific and financial support of MMV, and as part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.
Novartis has built the industry’s largest pipeline of treatments to control or eliminate malaria and neglected tropical diseases, backed by more than $500 million in funding for global health R&D since 2021. This includes four new non-artemisinin antimalarial compounds with the potential to combat rising drug resistance.