CHENNAI: Swiss-pharma major Novartis AG said early this week that its pediatric malaria treatment, Coartem Baby, received regulatory approval from Swissmedic, Switzerland's national medicines regulatory authority. This marks a milestone in global health, as this Novartis drug is the world's first malaria treatment specifically developed for newborns and infants weighing between 2 and 5 kilograms.
Coartem Baby is a reformulation of the existing Coartem (artemether-lumefantrine) combination therapy. The new formulation was developed through a collaboration between Novartis and the Medicines for Malaria Venture (MMV), with support from the PAMAfrica consortium.
The clinical development program was co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The approval was based on positive data from the Phase II/III CALINA study, which demonstrated that Coartem Baby has a pharmacokinetic profile suitable for infants under 5 kilograms and exhibits good efficacy and safety.
Global Health Impact
Malaria remains one of the world's deadliest diseases, particularly among children under five years old in Africa. In 2023, there were an estimated 36 million pregnancies in 33 African countries where malaria is widespread, with about one in three mothers infected with malaria during pregnancy, raising the risk of transmission to their newborns.
According to MMV sources, artemether-lumefantrine (infant) addresses a critical treatment gap for this vulnerable population, providing a safe and effective therapy for newborns and infants with malaria.
Distribution Strategy
Novartis plans to distribute this drug on a largely not-for-profit basis, aiming to increase access in malaria-endemic regions. The company is working with international partners and health organisations to ensure rapid and equitable distribution of the medication.
The approval of Coartem Baby represents an important advancement in the fight against malaria, offering a tailored treatment option for newborns and infants. Through strategic partnerships and a commitment to equitable access, this drug is poised to make a meaningful impact on global health by addressing the needs of one of the most vulnerable patient groups.