Novartis Achieves Historic Approval for Pioneering Malaria Treatment for Newborns and Young Infants

Novartis achieved a major milestone in global child health with the Swissmedic approval of Coartem® Baby (artemether-lumefantrine), the world’s first malaria treatment tailored for newborns and young infants weighing 2 to less than 5 kg. This addresses a critical gap, as no prior antimalarial drug was approved for infants under 4.5 kg, who faced risks from overdosing on older children’s formulations. Known as Riamet® Baby in some regions, the treatment was developed with Medicines for Malaria Venture (MMV) to combat acute, uncomplicated Plasmodium falciparum or mixed infections. Its dissolvable, cherry-flavored form can be mixed with breast milk, easing administration.

Eight African countries—Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda—participated in the regulatory process and are expected to fast-track approvals under the Marketing Authorization for Global Health Products framework. Novartis plans to distribute Coartem Baby on a largely not-for-profit basis to enhance access in malaria-endemic areas. The approval stems from the CALINA Phase II/III trial, which adjusted the artemether-lumefantrine dosage for infants’ unique metabolic needs, addressing risks from immature liver function.

Vas Narasimhan, Novartis CEO, emphasized the company’s 30-year commitment to malaria control, stating, “We are proud to ensure even the smallest and most vulnerable receive the care they deserve.” Professor Umberto D’Alessandro from the London School of Hygiene and Tropical Medicine noted the treatment’s importance, as prior drugs were tested only on children over six months. Supported by the PAMAfrica consortium, funded by EDCTP and Sida, MMV’s Martin Fitchet hailed it as a vital addition to the antimalarial toolkit. With 30 million babies born annually in malaria-risk African regions and infection rates of 3.4% to 18.4% in infants under six months, this approval bolsters efforts to reduce child mortality.