Swiss Approval of Coartem Baby Marks Major Advance in Infant Malaria Treatment

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 each year, nearly all in Africa. The newly approved medication, Coartem Baby, is a combination of two antimalarials and is a lower dose version of a tablet previously approved for other age groups, including older children. This approval marks a crucial step forward in providing effective treatment for infants who are particularly vulnerable to the deadly effects of malaria.

Swissmedic gave a green light for the medicine from Basel-based pharmaceutical company for treatment of babies with body weights between 2 and 5 kilograms, 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. This development is expected to have a profound impact on reducing malaria-related mortality rates among infants, who are among the most at-risk populations.

The significance of this approval cannot be overstated. Malaria remains a major public health challenge, particularly in Africa, where the disease continues to take a heavy toll on the population. The introduction of Coartem Baby offers a new line of defense against this deadly disease, providing healthcare providers with a tool to better protect and treat the youngest and most vulnerable patients. The drug's approval is a result of a fast-track authorization process, in coordination with the World Health Organization, to help developing countries access needed treatment.

Dr. Quique Bassat, a malaria expert, noted that the burden of malaria in very young children is relatively low compared to older kids. However, he emphasized the importance of access to such medicines for all age groups. “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. 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.

Ruairidh Villar, a 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, 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.