Novartis Gets Swiss Approval For First Malaria Drug For Babies

Swissmedic, the Swiss Agency for Therapeutic Products, approved Novartis AG’s NVS Coartem (artemether-lumefantrine) Baby on Tuesday. This marks the first malaria medicine specifically approved for newborns and young infants.

The new treatment, also known as Riamet Baby in some countries, was developed in collaboration with Medicines for Malaria Venture (MMV).

Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms. They have instead been treated with formulations intended for use in older children, which may increase the risk of overdose and toxicity, the company said in a statement on Tuesday. Malaria vaccines are also not approved for the youngest babies.

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Malaria, caused by a parasite and spread to humans by some mosquitoes, remains a global health concern, particularly in Africa. According to the most recent WHO data, there were 263 million cases of malaria and 597,000 deaths in 2023, almost all of them in Africa. Children under 5 years old accounted for about three in four malaria deaths in the region.

Some 30 million babies are born in areas of malaria risk in Africa every year, with one large survey across West Africa reporting infections ranging between 3.4% and 18.4% in infants younger than 6 months old. However, current data on malaria in young babies is minimal, as they are rarely included in clinical trials of antimalarial agents.

Novartis plans to introduce Coartem Baby on a largely not-for-profit basis to support access to care in malaria-endemic regions. The treatment is dissolvable, including in breast milk, and has a sweet cherry flavor to aid administration to infants.

The Swissmedic approval is based on the Phase 2/3 CALINA study, which investigated a new ratio and dose of Coartem (artemether-lumefantrine) to account for metabolic differences in babies under 5 kilograms.

The treatment is indicated for infants and neonates weighing between 2 and less than 5 kilograms with acute, uncomplicated infections caused by Plasmodium falciparum or mixed infections including P. falciparum. Coartem is known by the brand name Riamet in Switzerland and some other countries.

Eight African countries also participated in the assessment process and are expected to issue rapid approvals for Coartem Baby under Swissmedic’s Marketing Authorization for Global Health Products procedure.

Novartis developed the new dose strength designed for young infants 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.

Price Action: NVS is trading lower by 0.25% to $121.82 premarket at last check Tuesday.

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