Never Heard of These ‘PRV’s’ but What a Potential Bonanza for the Recipients. They’re transferable – as in they can be SOLD!

David Riley, Duke University

Regulatory Affairs Professionals Society (RAPS) February 2020

Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special “priority review” vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.

Last updated on 25 February 2020 to include:

  • Vifor Pharma said on 17 February that it purchased a PRV, and said on 25 February the PRV was purchased from Sarepta Therapeutics. The company said in an SEC filing that the PRV will be used to speed the review of vadadustat, which is a treatment for anemia due to chronic kidney disease. Vifor purchase the PRV for $111 million, according to Sarepta.
  • According to a new report from GAO on PRVs, Gilead was the unknown purchaser of Ultragenyx’s second PRV for about $80 million. Gilead said last month that it has used the voucher to speed the review of filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). 
  • Novartis confirmed to Focus that it will use two of its PRVs to speed the approvals of ofatumumab to treat multiple sclerosis and Cosentyx (secukinumab) for axial spondyloarthritis. Novartis said: “FDA decisions for both are expected in the first half of 2020.”
  • Merck won a PRV for the approval of its Ebola vaccine.
  • Bavarian Nordic sold its PRV for $95 million.
  • Sarepta Pharmaceuticals received a PRV for the accelerated approval of Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. This is Sarepta’s second PRV (the first was sold to Gilead).
  • How Jazz Pharmaceuticals plans to use the PRV it purchased from Spark Therapy.

Read the full 20-page article here, it’s amazing.

Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

RELATED: Immix Biopharma (IMMX) $5.74 Receives Rare Pediatric Disease Designation (“RPDD”) qualifies Immix Biopharma to receive fast track review, and a priority review voucher (“PRV”) at the time of marketing approval of IMX-110.