Drug Development

Sarepta lands a valuable priority review voucher on Exondys 51 OK

The FDA has issued a priority review voucher to Sarepta, which it’s already been hawking to deep-pocket drug developers.

The biotech won the PRV — good to anyone who buys it for a speedy agency review four months shorter than the norm — after winning approval for eteplirsen. The drug is now being sold for $300,000 a year as Exondys 51, the first drug approved for Duchenne muscular dystrophy in the US.

Grabbing the PRV under the radically accelerated approval, granted by Janet Woodcock, could be worth quite a bit of money to Sarepta. Once they hit the market a few years ago, big biopharmas bid up their value to as much as $350 million to gain an edge on launching top products.

In interviews right after the approval came through, Sarepta CEO Ed Kaye told FierceBiotech that the company was holding an auction for the PRV, one reason — though certainly one of many — that its stock price bolted higher. At the time he said that the PRV sale “should raise a lot of capital.”

The good news at Sarepta, though, won’t get any cheers at the FDA. The agency has been lobbying against renewal of the PRV legislation, saying that there’s no evidence that they helped inspire more research in difficult fields, as lawmakers intended. And there’s some clear resentment at being forced to take on some of these drugs as an urgent issue.

Jacob Plieth at EP Vantage supplied us with a breakdown on what these PRVs have fetched so far:

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