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

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

Swissmedic gave a green light Tuesday for 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.

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 authorization process, in coordination with the World Health Organization, to help developing countries access needed treatment.

The newly approved medication, Coartem Baby, is a combination of two antimalarials. It is a lower dose version of a tablet previously approved for other age groups, including older children.

Dr. Quique Bassat, a malaria expert not affiliated with the Swiss review, said 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.

Dr. Bhargavi Rao, co-director of the Malaria Centre at the London School of Hygiene and Tropical Medicine, noted that malaria cases continue to rise — especially in crisis-hit countries — despite new vaccines and programs targeting the mosquitoes that spread the parasite.

She said access strategies for the new medicine must include a look at where needs are greatest, and urged clarity on pricing.

''We need transparency around what Novartis' ‘largely not for profit' statement means including publicly available pricing, which countries will benefit and how long for,'' she wrote in an email.

Still, she said it was ''significant to finally have a suitable and safe treatment for very young children — more than 20 years since WHO first pre-qualified Coartem for older age groups.

She noted the announcement comes as resistance to antimalarials has been growing and many traditional donor countries have been sharply cutting outlays for global health — including for malaria programming and research.

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.