Launched in 2012 under the US Food and Drug Administration’s (FDA) Safety and Innovation Act, Rare Pediatric Disease PRV’s specifically target and support the development of new drugs and biological products for certain, rare paediatric diseases.
Upon approval, the rare paediatric voucher can be redeemed to review any drug under priority review, or it can be transferred or sold an unlimited number of times.
Following the FDA’s Biologics License Application (BLA) approval for lovo-cel and the PVA, under the terms of the agreement, all rights to the PRV will be transferred to the buyer and bluebird will receive $103m upon closing of the sale.
