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ARTICLE | Clinical News

FDA panel votes in favor of GSK's malaria candidate

July 13, 2018 6:53 PM UTC

FDA's Antimicrobial Drugs Advisory Committee voted 13-0 that there is substantial evidence of the effectiveness of tafenoquine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to prevent relapse of Plasmodium vivax malaria in patients 16 and older, and 12-1 that there is adequate evidence of safety. GSK said that if the candidate is approved, tafenoquine would be the first new medicine for this indication in more than 60 years.

Tafenoquine, an 8-aminoquinoline derivative, has breakthrough therapy designation from FDA. The proposed U.S. proprietary name for tafenoquine is Krintafel...

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