FDA Approves First Malaria Drug in 60 Years
The FDA has approved the first new option for malaria in more than 60 years.
Single-dose Krintafel (tafenoquine) was approved for the radical cure of Plasmodium vivax (P vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P vivax infection.
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This approval was based upon the efficacy and safety data from 33 studies involving more than 4000 individuals exposed to the 300 mg single-dose and other doses of tafenoquine.
The drug, which acts against all stages of the P vivax life cycle, was first synthesized in 1978.
The most common adverse reactions included dizziness, nausea, vomiting, headache, and decreased hemoglobin.
US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria [press release]. July 20, 2018. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-krintafel-tafenoquine-for-the-radical-cure-of-p-vivax-malaria/.