While the price of just about everything has increased over the last six years in the U.S., the same can’t be said for the cost of an FDA priority review voucher. Just ask Sarepta Therapeutics.
Since 2017, the Massachusetts rare disease specialist has sold off three PRVs—getting less in return for each one.
The most recent sale came Wednesday as Sarepta revealed a $102 million deal for its PRV that came along with the FDA’s endorsement two weeks ago of the company’s latest Duchenne muscular dystrophy (DMD) treatment, gene therapy Elevidys.
“The name of the buyer is not being disclosed by either company,” a Sarepta spokesperson said in an email.
The purchaser can use the voucher to speed the review of a drug application from 10 to six months, which can potentially provide a key advantage for companies that are in competition with others to market a new therapy.
In 2017, after Sarepta won approval for DMD drug Exondys 51, the company sold the accompanying PRV to Gilead Sciences for $125 million. Then in 2020, after it secured an FDA green light for Vyondys 53, Sarepta cashed in the PRV for $111 million from Vifor Pharma, which used the voucher to speed an FDA decision on its kidney disease drug vadadustat.
In each case, Sarepta sold the PRV in lieu of holding onto it to speed the application of its next DMD candidate.
The FDA issues PRVs to incentivize companies to develop medicines for rare diseases where there are few or no treatment options for patients. The FDA established the program in 2009 for tropical diseases and extended it five years later for rare pediatric conditions.
PRVs were once valued much more highly. In 2015, AbbVie paid United Therapeutics $350 million to secure a voucher. But the price for recent PRVs have been falling. Last year, bluebird bio sold vouchers after winning a pair of FDA gene therapy approvals. In November, Argenx bought a PRV from bluebird for $102 million. Then early this year, Bristol Myers Squibb paid bluebird $95 million for another PRV.