Novartis Gets Swiss Authority Nod For First Malaria Drug In Newborns, Young Infants

Novartis (NVS) on Tuesday said that Swiss authorities have approved its Coartem Baby as the first malaria medicine for newborns and young infants.

Novartis developed the treatment, also known as Riamet Baby in some geographies, in collaboration with Medicines for Malaria Venture (MMV).

The company said that it now expects rapid approval for the treatment in eight African countries, including Burkina Faso, Côte d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Uganda, and Tanzania.  

Malaria is a life-threatening disease caused by a parasite and spread to humans by some types of mosquitoes. Novartis cited WHO data and noted that there were 263 million cases of malaria and 597,000 deaths in 2023, almost all of them in Africa. 

The company said it intends to introduce the infant-friendly treatment on a largely not-for-profit basis where malaria is endemic. According to Novartis, some 30 million babies are born in areas of malaria risk in Africa every year.

The new approval is for the treatment of malaria in infants weighing between 2kg and 5kg. Novartis said there were no approved malaria treatments for infants weighing less than 4.5kg until now, leaving a treatment gap. Furthermore, malaria vaccines are also not approved for the youngest babies, the company noted.

The pediatric formulation of the treatment is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer.

“The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox,” CEO of MMV Martin Fitchet said.

On Stocktwits, retail sentiment around Novartis is trending in the “bullish” territory, coupled with “high” message volume.

NVS stock is up by about 26% this year and by 13% over the past 12 months.

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