Swiss pharmaceutical company Novartis (NYSE: NVS) has announced interim results from a Phase II/III clinical trial for its antimalarial drug Coartem (artemether + lumefantrine) in infants with uncomplicated Plasmodium falciparum malaria. The trial data indicates that the tablet formulation meets pharmacokinetic (PK), efficacy, and safety requirements, achieving the primary PK endpoint in patients over 28 days of age.
Coartem, in collaboration with Medicines for Malaria Venture (MMV), could become the first-ever treatment approved for babies with malaria. The results are currently under regulatory review and, if approved, would significantly impact the treatment landscape for this vulnerable population.- Flcube.com
