Novartis Gains World-First Approval of Malaria Treatment for Babies

Novartis received approval from Swissmedic—the Swiss health regulator—for Coartem Baby, making it the first malaria treatment approved specifically for newborns and young infants weighing between 2 and 5 kilograms (up to 4.5 kg in some sources)135.

The approval was granted on July 8, 2025, and was achieved through a collaboration between Novartis and the Medicines for Malaria Venture (MMV), a nonprofit dedicated to expanding malaria treatment options15.

The new medicine, also known as Riamet Baby in some countries, contains artemether-lumefantrine and is designed for babies and very young children who are highly vulnerable to malaria35.

Swissmedic's approval occurred under the Marketing Authorization for Global Health Products (MAGHP) scheme, which enables rapid regulatory approvals in eight African countries expected to follow quickly135.

Novartis plans to introduce Coartem Baby on a largely not-for-profit basis to increase access in regions where malaria is endemic, particularly benefiting the most vulnerable populations135.

The approval is considered a historic milestone in providing clinically proven malaria treatment for the youngest age group, addressing a critical unmet medical need15.

Sources:

1. https://www.fiercepharma.com/pharma/novartis-malaria-drug-babies-wins-world-first-approval

3. https://www.mmv.org/newsroom/news-resources-search/first-malaria-medicine-newborn-babies-and-young-infants-45-kg

5. https://www.novartis.com/news/media-releases/novartis-receives-approval-first-malaria-medicine-newborn-babies-and-young-infants