In a significant medical breakthrough, Swissmedic Switzerland’s national health authority has granted approval to a newly developed malaria treatment designed specifically for newborns. The medication, developed by Swiss pharmaceutical company Novartis, is tailored for infants weighing between 2 and 5 kilograms, marking the first targeted treatment for this vulnerable age group.
First-Ever Malaria Drug For Newborns
Approved on July 9, 2025, this drug represents a critical step toward addressing the lack of appropriate malaria treatments for very young infants. The medication underwent fast-track evaluation by Swissmedic in collaboration with the World Health Organization (WHO). This expedited process is part of a global effort to accelerate access to life-saving medicines in low- and middle-income countries, especially those severely affected by malaria.
Why This Development Is Crucial For Africa
Malaria continues to be a leading cause of death among children in sub-Saharan Africa. According to WHO data, 95% of the 597,000 global malaria deaths in 2023 occurred on the African continent, with most victims being children under five years old. Infants, though often overlooked, are at high risk. Until now, treatments meant for older children had to be modified for newborns, a method described by health professionals as unsafe and imprecise.
Expert Endorsements And Regional Rollout Plans
Dr. Quique Bassat, a prominent malaria researcher from the Barcelona Institute for Global Health (ISGlobal), praised the approval, stating the new formulation is both clinically safe and easy to administer, offering an improved solution for infant treatment.
According to Novartis spokesperson Ruairidh Villar, eight African nations actively participated in the regulatory review. These countries are expected to grant local approvals within the next 90 days, making the drug available across key malaria-endemic regions. Villar also emphasized that Novartis intends to distribute the medicine on a not-for-profit basis in these regions to ensure maximum accessibility.
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