Swissmedic has approved Novartis’ Coartem Baby, marking the first malaria medicine for newborns and young infants.
The new treatment, also known as Riamet Baby in some countries, is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer.
The Swissmedic approval is based on the phase 2/3 CALINA study, which investigated a new ratio and dose of Coartem to account for metabolic differences in babies under 11 lbs. (5 kg). Until now, there has been no approved malaria treatment for infants weighing less than 10 lbs. (4.5 kg), leaving a treatment gap. Novartis' Coartem, a fixed-dose combination of two novel antimalarials, was approved by the FDA in 2009 for use by adults and children weighing at least 11 lbs.
The new dose strength designed for young infants was developed by Novartis with the scientific and financial support of Medicines for Malaria Venture (MMV), and as part of the PAMAfrica consortium. Eight African countries also participated in the assessment and are now expected to issue rapid approvals under the Swiss agency’s Marketing Authorization for Global Health Products procedure.
Novartis says it plans to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in areas where malaria is endemic.