Novartis and Medicines for Malaria Venture (MMV) announce positive efficacy and safety data for a new treatment for malaria-infected babies under 5 kg.

The positive data come from the Phase II/III CALINA study, demonstrating that a new formulation of Coartem ® (artemether-lumefantrine) developed for malaria-infected babies under 5 kg has the required pharmacokinetic profile and good efficacy and safety.

The trial was conducted in several African countries. The data, which will be presented this week at the 8th Pan-African Malaria Conference of the Multilateral Initiative on Malaria (MIM Society) in Kigali, have been submitted for regulatory review.

' We are delighted with the positive results of our CALINA study and to be one step closer to introducing an effective malaria treatment for all age groups, including vulnerable newborns ', said Shreeram Aradhye, President of 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 step towards ensuring that everyone has access to appropriate antimalarial treatment.''

Novartis and MMV aim to make treatment available as soon as possible to the youngest infants, who currently lack access to evidence-based treatment options.

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