Tracking The Priority Review Vouchers
A chart showing the status of the 10 FDA priority review vouchers awarded to date for tropical disease and rare pediatric disease treatments.
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Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.
US FDA program's new 2020 sunset could create a bolus of designation requests to ensure they can still get a voucher if it ends.
Final guidance on the tropical disease priority review voucher program says FDA will adhere to priority review goals, which allow agency to complete some outside the stated time frame.