Novartis announced that the World Health Organization has prequalified Coartem® Baby, its artemether‑lumefantrine formulation designed for infants weighing 2 to 5 kg. The prequalification, granted on April 24 2026, is the first step toward WHO‑procured procurement and will enable the drug to be distributed in malaria‑endemic regions on a not‑for‑profit basis.
Coartem Baby is the first antimalarial specifically developed for newborns and young infants, filling a critical treatment gap that previously required the use of formulations intended for older children. The product was first approved by Swissmedic in July 2025 and was developed in partnership with Medicines for Malaria Venture (MMV), underscoring a collaborative effort to bring a life‑saving therapy to the most vulnerable population.
The not‑for‑profit distribution model means that Coartem Baby will be supplied to national health systems and donor‑funded programs at cost, ensuring that access is not limited by commercial pricing. WHO prequalification also signals that the product meets rigorous quality, safety, and efficacy standards, making it eligible for procurement by global health agencies such as UNICEF, the Global Fund, and the World Bank.
From a business perspective, the prequalification expands Novartis’s presence in the global malaria market and reinforces its commitment to neglected tropical disease innovation. While the product will be sold on a largely not‑for‑profit basis, the move enhances the company’s reputation, strengthens relationships with public‑health partners, and positions Novartis to respond to future demand for pediatric antimalarials in high‑burden countries.
"This decision takes us one step closer to ensuring that the tiniest babies have access to the first antimalarial designed specifically for them," said Dr. Lutz Hegemann, President of Global Health at Novartis. Dr. Martin Fitchet, CEO of MMV, added, "WHO prequalification of Coartem Baby is a major public health milestone and reflects MMV's commitment to ensuring that even the smallest and most vulnerable patients are not left behind." WHO’s Dr. Daniel Ngamije Madandi noted, "This new formulation represents an innovation as there are no antimalarial medicines specifically developed for the treatment of uncomplicated malaria in children from 2 to 5 kilograms body weight." A pediatrician in Ghana, Dr. Emmanuel Aidoo, observed, "Having a new treatment tailor‑made for infants that is well tolerated gives us confidence in caring for our youngest patients."
The prequalification comes at a time when malaria remains a leading cause of morbidity and mortality in sub‑Saharan Africa. WHO data from 2024 reported 282 million cases and 610,000 deaths worldwide, underscoring the urgent need for age‑appropriate therapies. Coartem Baby’s availability is expected to improve treatment outcomes for infants, reduce mortality, and support global efforts to eliminate malaria.
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