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.
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