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GSK Moves Closer To Priority Review Voucher As US Panel Backs Malaria Drug Tafenoquine

 
• By Sue Sutter

GlaxoSmithKline's user fee date is July 22, four days before advisory committee review of 60 Degrees’ separate application for the compound.

FDA Advisory Committee Feature image

A US FDA advisory committee’s overwhelming endorsement of the efficacy and safety of GlaxoSmithKline PLC’s Krintafel (tafenoquine) for prevention of malaria relapse positions the company to nab a tropical disease priority review voucher by the application’s July 22 user fee deadline.

On July 12, the Antimicrobial Drugs Advisory Committee voted 13-0 that GSK provided substantial evidence tafenoquine is effective for the radical cure (prevention of relapse) of

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