Novartis Scores World-First Approval for Malaria Drug Targeting Infants

Novartis, in collaboration with Swiss nonprofit Medicines for Malaria Venture (MMV), has achieved a groundbreaking milestone in the fight against malaria. The pharmaceutical giant has secured the world's first approval for a malaria treatment specifically designed for infants weighing between 2 and 5 kilograms (4.4 and 11 pounds).

Swiss Regulator Greenlights Coartem Baby

Switzerland's health regulator, Swissmedic, has granted approval for Coartem Baby, a new formulation of the established antimalarial drug Coartem. This approval, issued under the Marketing Authorization for Global Health Products (MAGHP) procedure, is expected to facilitate rapid approvals in eight African nations where malaria is endemic.

Coartem Baby represents a significant advancement in pediatric malaria treatment. The dissolvable formulation can be administered with breast milk and features a sweet cherry flavor to improve palatability for infants. Novartis CEO Vas Narasimhan emphasized the company's commitment, stating, "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."

Addressing a Critical Gap in Malaria Treatment

The approval of Coartem Baby addresses a crucial need in malaria treatment for very young infants. Umberto D'Alessandro of The Gambia at the London School of Hygiene and Tropical Medicine highlighted the significance of this development: "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. 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."

The World Health Organization reported 263 million cases of malaria in 2023, resulting in 597,000 deaths, with 76% of fatalities occurring in children under five years old. The approval of Coartem Baby is based on a phase 2/3 study that investigated a new dosage regimen accounting for metabolic differences in infants under 5 kilograms.

Novartis' Commitment to Neglected Tropical Diseases

While some pharmaceutical companies have reduced their focus on Neglected Tropical Diseases (NTDs), Novartis has intensified its efforts. The company has nearly doubled its R&D spending on NTDs, advancing 10 new treatments. Beyond malaria, Novartis is actively pursuing treatments for dengue fever, Chagas disease, leishmaniasis, and cryptosporidiosis.

Martin Fitchet, CEO of MMV, underscored the potential impact of this approval: "Malaria is one of the world's deadliest diseases, particularly among children. 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."

Novartis plans to introduce Coartem Baby on a "largely not-for-profit basis" to increase access in malaria-endemic areas. The company's portfolio includes four next-generation malaria medicines, with one currently undergoing phase 3 clinical trials to address the increasing resistance to existing treatments.