Switzerland Clears First Malaria Medicine for Small Babies
Swissmedic, the medical authority of Switzerland, approved a new malaria treatment that has been specifically designed for small infants. The treatment, developed by Novartis, received approval on July 9, 2025, to treat babies who weigh between 2 and 5 kilograms. This approval is significant, as malaria contributes to innumerable child fatalities, particularly in Africa.
An Important Step for Infant Health
Novartis is a pharmaceutical company based in Basel, Switzerland. The new medicine is the first malaria treatment to be approved for very young infants, which represents an important step for protecting the youngest and most vulnerable children. The approval took place under the fast-track process of Swissmedic, done in close coordination with the World Health Organization (WHO). Depending on the treatment, the process allows the agency to fast-track medicines intended for importing to countries in the world where development is slower and progress can take longer.
Why This is Important for Africa
In 2023, malaria was estimated to have claimed 597,000 lives worldwide, with 95% of fatalities occurring in Africa. Children aged under five years were impacted more than any other age group. Although the disease normally impacts children between three and six months, access to safe and effective treatment options, including access to the specific medicine, should also be available to infants. Up until this point, infants have only been able to access medicines used for older children, which was a “suboptimal” solution for experts.
Expert Opinions and Companies Plan
Quique Bassat, malaria specialist at ISGlobal (Barcelona Institute for Global Health), has stated that the drug is both safe and efficacious. It should facilitate treatment for infants in a safer and simpler way.
Ruairidh Villar, spokesperson for Novartis, said eight African countries have been involved in the review of the drug and are set to approve it within 90 days. Novartis intends to sell the drug largely at no profit in the countries with significant malaria.