Swiss medicines authority issues first approval for antimalarial drug for treatment of infants

Switzerland’s medical products authority has granted the first approval for a malaria medicine designed for small infants, touted as a breakthrough against a disease that takes hundreds of thousands of lives — nearly all in Africa — each year.

Swissmedic gave a green light Tuesday for use of the medicine from Basel-based pharmaceutical company Novartis for treatment of babies with body weights between 2 and 5 kilograms (nearly 4½ to 11 pounds), which could pave the way for hard-hit African nations to follow suit in coming months.

Sigificance of infant-designed version of the medicine

The agency said that the decision is “significant” in part because it’s only the third time it has approved a treatment under a fast-track authorisation process, in coordination with the World Health Organization, to help developing countries access needed treatment.

The infant-designed version of the medicine has already been approved for other age groupsincluding older children. Quique Bassat, a malaria expert not affiliated with the Swiss review, said that the disease typically becomes frequent in most-affected areas after children reach 3 to 6 months of age, and the burden of malaria in very young children is “relatively low” compared to older kids.

But access to such medicines is important to all, he said.“There is no doubt that any child of whichever age — and particularly very, very young ones or very light-weighted ones — require a treatment,” said Bassat, the director- general of the Barcelona Institute for Global Health, known as ISGlobal.

Up to now, antimalarial drugs designed for older children have been administered to small infants in careful ways to avoid overdose or toxicity, in what Bassat called a “suboptimal solution” that the newly designed medicine could help rectify. “This is a drug which we know is safe, we know works well, and therefore it will just be available as a new version for a specific age group,” he said.

Ruairidh Villar, a Novartis spokesperson, said that eight African countries took part in the assessment and are expected to approve the medicine within 90 days. The company said that it’s planning on a rollout on a “largely not-for-profit basis” in countries where malaria is endemic.

The mosquito-borne illness is the deadliest disease in Africa, whose 1.5 billion people accounted for 95% of an estimated 597,000 malaria deaths worldwide in 2023, according to WHO. More than three-quarters of those deaths were among children.