The Swiss therapeutic products agency Swissmedic has approved the use of the first malaria drug for newborns and infants, the drug’s developer Novartis said in a press release on Tuesday.
The drug has been named Coartem Baby, and Riamet Baby for certain markets. Representatives from eight African countries also participated in evaluating the drug’s efficacy and safety, and the licensing process is expected to be completed there soon. The drug will be distributed on a non-profit basis.
“Together with our partners, we are proud to have taken the next step in research and developed the first malaria drug for newborns and infants that has passed clinical trials, which will help ensure that even the smallest and most vulnerable can finally get the help they need,” company CEO Vas Narasimhan said in a press release.
The company explained that until now, there were no drugs available to treat malaria in infants weighing less than 4.5 kg (this range covers most newborns), so they were treated with drugs intended for older or larger children, which carried a risk of overdose and poisoning. In addition, there are currently no malaria vaccines for infants. According to the latest data from the World Health Organisation, more than 260 million people contracted malaria in 2023, with nearly 600,000 deaths, all of which occurred in African countries. Children under the age of five account for about three-quarters of the deaths.
“Malaria is one of the deadliest diseases, especially among children. But with the right resources and priorities, it can be eradicated. The registration of Coartem Baby provides the necessary medicine in the optimal dosage to treat a group of patients who have not been the focus of attention before,” said Martin Fitch, head of the non-profit partnership Medicines for Malaria Venture, which participated in the development of the drug.
