Another Priority Review Voucher (PRV) Sold, This Time for $125 Million
Here’s an important follow-up from Zach Brennan at the RAPS website on the FDA’s priority review voucher (PRV) program.
Sarepta just sold its PRV (which it received with the controversial FDA approval of the first-in-class DMD drug eteplirsen in September) to Gilead for $125 million.
According to Brennan, this is Gilead’s third purchased PRV, one of which has been used already to accelerate approval of a combination HIV pill. Against some expectations, the sale value of PRVs has not escalated; $125 million is “in the middle of the pack,” according to Brennan, with a PRV price tag ranging so far from $67 million to $350 million.
Brennan writes that there are 5 remaining (that is, unused) PRVs, and this number is likely to increase with Congress’s reauthorization of the PRV program for rare pediatric diseases (extended to October 2020) and the creation of a new PRV program for medical countermeasures (expiring October 2023). The PRV program for neglected tropical diseases continues. Senators Claire McCaskill and Susan Collins also hope to legislate a PRV program to hasten generic approval.
Generally the FDA has not been a fan of PRVs, primarily because they upset the agency’s already overloaded work flow.
* One of which was awarded to Biogen/Ionis for the approval of nusinersen in December, the first drug for spinal muscular atrophy, and 1 to Marathon for the controversial approval of deflazacort earlier this month.