First-Ever Infant Malaria Treatment Gets Swiss Approval

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First-Ever Infant Malaria Treatment Gets Swiss Approval

The recent approval of Coartem Baby by Swissmedic marks a significant advancement in the fight against malaria, particularly for vulnerable populations such as infants. This groundbreaking treatment is specifically formulated for newborns and young children weighing between 2 to 5 kilograms . As malaria continues to pose a severe health risk in endemic regions, the introduction of this lower-dose medication addresses a critical gap in existing treatment options for infants, who have historically been underserved in this domain .

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.

    Until 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.

    Coartem Baby is a lower-dose formulation of an existing antimalarial medication and has been designed with ease of administration in mind. Its dissolvable nature allows it to be mixed with breast milk and its cherry flavor enhances acceptability among infants. The anticipated rapid approvals from several African countries reflect the urgent need for effective treatments that are both safe and accessible to vulnerable populations . However, experts emphasize the importance of equitable distribution systems to ensure that this life-saving medication reaches those who need it most.

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