GENEVA, July 11 — Swiss regulators have approved the first-ever antimalarial drug specifically designed for newborns weighing less than 11 pounds, marking a breakthrough in efforts to treat the disease in the most vulnerable infants.
Pharmaceutical giant Novartis developed the new formulation of artemether-lumefantrine, designed as a cherry-flavored, rapidly dissolving tablet that can be given to very young infants unable to swallow pills or tolerate bitter medicine. The approval means health systems in malaria-endemic regions, especially in Africa, can now begin the process of importing and distributing the drug for the smallest babies.
Until now, infants under 5 kilograms (11 pounds) had no approved treatment for malaria, forcing doctors to improvise dosages of existing drugs—often with uncertain outcomes. According to the AP, about 260,000 African children under five die from malaria every year, many in the first few months of life.
“This approval is a significant milestone,” a Novartis representative said in the original article. The company will next apply for WHO prequalification, which is essential for use by global health agencies.