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.

—Michael Potts

Reference:

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/.