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Posted by on Feb 21, 2017 in FDA, Legislation, Pharma

Another Priority Review Voucher (PRV) Sold, This Time for $125 Million

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.



bmartin (1082 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.