Novartis, MMV announce data for Phase II/III CALINA study of Coartem

Novartis and Medicines for Malaria Venture, MMV, announce positive data from their phase II/III CALINA study, demonstrating that a novel formulation of Coartem developed for babies weighing less than 5kg with malaria has the required pharmacokinetic profile and good efficacy and safety. The data, which will be presented this week at the Multilateral Initiative on Malaria 8th Pan-African Malaria Conference in Kigali, have been submitted for regulatory review. “We are pleased with the positive outcomes from our CALINA study and to be one step closer to bringing an effective malaria treatment to all age groups, including vulnerable newborn babies,” said Shreeram Aradhye, President, Development and Chief Medical Officer at Novartis. “We have been committed to the fight against malaria for more than two decades, and this successful trial represents another milestone towards ensuring that all people have access to an appropriate antimalarial therapy.” The CALINA study is led by Novartis. It is the first evidence-based trial conducted to evaluate a new antimalarial dose and regimen for all infants weighing under 5 kg with acute uncomplicated malaria.