Definition
Priority Review Voucher (PRV) is a transferable incentive awarded by FDA upon approval of drugs for neglected tropical diseases, rare pediatric diseases, or medical countermeasures. The voucher entitles the holder to Priority Review (6 months) for any subsequent NDA or BLA.
How PRV Works
Sponsors earn a PRV by successfully developing and gaining approval for drugs treating specified diseases. The voucher can then be used by the sponsor or sold to another company for use on any drug application.
Voucher-Granting Programs
- Neglected Tropical Disease PRV (since 2007)
- Rare Pediatric Disease PRV (since 2012)
- Medical Countermeasure PRV (since 2016)
PRV Transaction History
| Transaction | Year | Price | Notes |
|---|---|---|---|
| BioMarin to Sarepta | 2014 | $67.5M | First public sale |
| United Therapeutics to AbbVie | 2015 | $350M | Record high |
| Sarepta to Gilead | 2016 | $125M | Pediatric PRV |
| Multiple | 2020-2025 | $100-200M | Stabilized pricing |
PRV Value Drivers
| Factor | Impact on Value |
|---|---|
| Supply (PRVs available) | More supply = lower price |
| Demand (pending NDAs) | More blockbusters = higher price |
| Time sensitivity | Urgent approvals pay premium |
| Negotiation leverage | Seller’s market historically |
Why BD Teams Track PRV
For business development professionals, PRVs represent tangible value:
- Deal Implication: PRV can add $100M+ to approval value; factor into asset valuation
- Due Diligence Focus: Track PRV eligibility status and program qualification
- Opportunity Signal: Companies with PRV-eligible programs may seek buyers before approval