
BASEL (dpa-AFX) - Novartis AG (NVS) and Medicines for Malaria Venture Wednesday said results from the phase II/III CALINA study showed the novel formulation of Coartem to treat babies weighing less than 5kg with malaria has the required pharmacokinetic profile and good efficacy and safety.
The new formulation, known as Coartem less than5 kg Baby, uses a new ratio and dose of artemether-lumefantrine considering metabolic differences in babies under 5kg, Novartis said in a statement.
Novartis said the data has been submitted for regulatory review.
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