Novartis and a Swiss nonprofit have made history, scoring the world’s first approval for a medicine to treat babies who are infected with malaria. Switzerland’s health regulator has signed off on Coartem Baby for infants who weigh between 2 and 5 kilograms (4.4 and 11 pounds) and have contracted the deadly mosquito-borne disease.

Coartem Baby was endorsed by Swissmedic under a prearranged Marketing Authorization for Global Health Products (MAGHP) procedure, which will facilitate rapid approvals in eight African nations, Novartis said in a July 8 press release.  The drugmaker plans to introduce the treatment on a “largely not-for-profit basis to increase access in areas where malaria is endemic," Novartis added.

“For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most,” Vas Narasimhan, Novartis’ CEO, said in the release. 

The pharma giant collaborated with Switzerland’s Medicines for Malaria Venture (MMV), a health-equity initiative established in 1999 to expand the use of antimalarials and innovate new compounds. Novartis has four next-generation malaria medicines in its portfolio—including one being tested in a phase 3 trial—to take on the increased resistance to existing treatments.   

“Malaria is one of the world’s deadliest diseases, particularly among children," Martin Fitchet, the CEO of MMV, said in the release. "But with the right resources and focus, it can be eliminated. The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients.” 

The nod is for a new formulation of Coartem, which is also known commercially in some countries as Riamet, and was launched by Novartis in 1999. It was approved by the FDA ten years later. It is a combination of antivirals artemether and lumefantrine. Coartem Baby is dissolvable, can be taken with breast milk and has a “sweet cherry flavor," Novartis said. 

The approval was based on a phase 2/3 study, which investigated a new dose of Coartem to “account for metabolic differences in babies under 5 kilograms,” Novartis said in the release.  

Countries that participated in the assessment and which are expected to endorse the treatment are Burkina Faso, Cote d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda. 

There were 263 million cases of malaria in 2023 and 597,000 deaths, nearly all of them in Africa, according to a recent World Health Organization report. Of the fatalities, 76% were children under age 5.  

“The available malaria treatments have only been properly tested in children aged at least 6 months because smaller infants are usually excluded from treatment trials,” Umberto D'Alessandro, of The Gambia at the London School of Hygiene and Tropical Medicine, said in a release. “Neonates and young infants have immature liver function and metabolize some medicines differently, so the dose for older children may not be appropriate for small babies.”  

While several other large pharma companies have backed away from the field of Neglected Tropical Diseases (NTDs) in recent years, Novartis has nearly doubled its R&D spending on NTDs, advancing 10 new treatments. The company is also pursuing treatments for dengue fever, Chagas disease, leishmaniasas and cryptosporidiosis.