Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs
US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.
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In citizen petition to US FDA, rare diseases nonprofit group asks agency to add sickle cell disease to its tropical disease PRV list since the disease predominantly impacts those who live in Africa and the African American population in the US.
Rare Pediatric Disease Designations May Be Unavailable After July As Program Renewal Remains Uncertain
Without new legislation, US FDA said that designations, which are required to receive priority review vouchers, cannot be assured if requested after July. While the window for designations formally closes at the end of September when the authorization of the program expires, the agency is telling sponsors that it needs 60 days before that to review any requests. If a product does get a designation, it would need to secure approval by 30 September 2022 to gain a priority review voucher.
Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.