From the FDA website, if my interpretation is correct, Rare Paediatric Priority Review Vouchers can be sold to other pharma companies (and have been) to accelerate the FDA review of any drug, whether it’s a rare paediatric disease or not.
The FDA however from Sep 30, 2024, will only allow PRVs to be used for accelerating reviews of rare paediatric diseases. The value of them could drop after this date as the buying market is significantly reduced.
And from Sep 30, 2026, the FDA will not be awarding them at all to any company for accelerated review, hence no likelihood of extension if approval is not reached by then.
Please correct me if I’m interpreting this wrong.
https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs
