Pair of Anti-Malaria Drugs Win Approval
The FDA signed off on two malaria treatments, one designed to help prevent relapse of the disease, the other a preventive measure.
The agency approved GlaxoSmithKline’s Krintafel (tafenoquine) after clinical trials of 522 malaria patients in eight sites in Asia, Africa and Latin America showed that taking Krintafel along with anti-malarial drug chloroquine for three days kept patients malaria-free for up to six months.
The FDA also greenlighted 60 Degrees Pharmaceuticals’ tafenoquine product Arakoda. It’s the first preventive malaria medicine to win federal approval in two decades. 60 Degrees worked with the U.S. Army to test the drug in 21 clinical trials involving 3,100 subjects.
Both companies will conduct post-marketing studies to make sure their drugs are safe and effective for children, elders and the obese.