Novartis Wins Approval for First Malaria Medicine for Babies

(Bloomberg) — Novartis AG won regulatory approval for the first medicine designed for babies with malaria, the latest development in the global fight against the mosquito-borne disease.

The Swiss drugmaker said Tuesday the country’s agency Swissmedic approved a new formulation of its drug Coartem to treat infants weighing from 2 kilograms to under 5 kilograms (11 pounds). The company expects approval from eight countries in Africa to follow, and plans to roll out the treatment on a “largely not-for-profit basis,” it said.

Until now, infants with malaria were typically treated with tablets meant for older children, adjusted for weight, the company said. The drug, also known as Riamet Baby in some countries, was developed with scientific and financial support of Medicines for Malaria Venture, a Swiss non-profit focused on antimalarial medicines. 

In 2023, there were 263 million malaria cases globally and 597,000 deaths, most of them in African countries, with children under 5 years old accounting for three in four deaths, according to the latest report from the World Health Organization. 

Novartis is developing other antimalarial treatments, including a compound to fight drug resistance, currently in late-stage trial, and another which is a potential single-dose cure. 

Shares in the company were down 0.5% at 1 p.m. in Zurich.

The approval offers a bright spot after deep cuts to the US Agency for International Development earlier this year raised concerns about the fight against malaria. A study published earlier this month warned that USAID cuts could result in over 14 million deaths by 2030 from different causes, including malaria and HIV/AIDS.

Meanwhile East Africa countries are boosting health spending to help fill the gap left by the agency’s pullback, with the region’s biggest economy Kenya planning to allocate about $130 million to an international partnership that fights HIV/AIDS, malaria and tuberculosis.

(Adds MMV backing for the drug to third paragraph.)

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