First malaria drug for newborns and young infants expected to be approved in Africa within weeks

CNN

6 days ago

The approval of the first malaria treatment for newborns and young infants could lead to imminent widespread use in Africa, drugmaker Novartis said Tuesday.
The drug, known as Coartem Baby or Riamet Baby in some countries, has been approved by Swiss authorities for use in babies weighing between 2 kilograms (4 pounds, 6 ounces) and 5 kilograms (11 pounds) and is formulated to be easy for them to take, Novartis said.
Coartem Baby already has approval in the West African nation of Ghana and Novartis said it now expects eight African countries to grant their own approvals within 90 days. The countries – Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda – also participated in the assessment of the drug.
Vas Narasimhan, chief executive of Novartis, said in a news release that this first clinically proven malaria treatment for newborns and young babies ensures 'even the smallest and most vulnerable can finally receive the care they deserve.'
Until now, the smallest babies have been treated for malaria, a potentially deadly disease spread by mosquitoes, with medications designed for older children. Novartis, the Swiss pharmaceutical corporation behind the newly approved drug, says this can expose newborns to the risk of overdose and toxicity.
'Most clinical trials have historically excluded babies under six months old,' Novartis spokesman Ruairidh Villar told CNN.
There were 263 million cases of malaria and 597,000 deaths in 2023 – nearly all of them in Africa, according to World Health Organization data. Children under the age of 5 accounted for about three in four malaria deaths in the region.
The medicine was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Switzerland-based not-for-profit organization.
Novartis told CNN that it plans to 'roll out the medicine in the coming weeks on a largely not-for-profit basis.'
'Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,' said Martin Fitchet, chief executive of MMV.
'The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.'