Novartis announced that the World Health Organization (WHO) has prequalified Coartem (artemether-lumefantrine) Baby, an antimalarial formulation developed specifically for newborns and young infants weighing 2 to 5 kilograms. Coartem Baby, also known as Riamet Baby in some countries, is the first and only malaria treatment designed for this weight group, addressing a long-standing gap in available therapies for very young infants.
WHO prequalification is a quality, safety, and efficacy assessment process used to guide public sector and donor-funded procurement of medicines for diseases such as malaria, HIV/AIDS, and tuberculosis. Products that complete this process are included on WHO lists used by United Nations agencies and other procurers to inform funding and purchasing decisions. The prequalification of Coartem Baby is expected to facilitate wider access through public sector supply channels in malaria-endemic regions.
Novartis stated that Coartem Baby is being made available on a largely not-for-profit basis in regions where malaria is endemic. The company has already introduced the treatment in Ghana and plans to work with partners to expand access to additional countries.
Historically, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, and the smallest infants have often been treated with formulations intended for older children. Coartem Baby was developed by Novartis with scientific and financial support from Medicines for Malaria Venture (MMV), and as part of the PAMAfrica consortium, co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.
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