- Draft guidance from the Food and Drug Administration is providing more detail on a new program that will expand the distribution of priority review vouchers (PRVs) to companies developing material threat medical countermeasures.
- The program covers diagnostics, therapeutics and prophylactics for conditions linked with chemical, biological, radiological and nuclear threats, and emerging infectious diseases.
- Because the development of material threat medical countermeasures is often supported by the U.S. government, and governments in the U.S. and elsewhere are generally the only customers, the PRV program will add an additional incentive to work in this area.
A PRV is effectively a thank you to drugmakers for bringing to market a treatment for a specific area. Already, companies could snag a PRV by developing an effective medicine for tropical diseases or rare pediatric disorders. Now, drugs for material threat medical countermeasures are on the list as well.
With a voucher in hand, companies can place another one of their drugs under priority review with the FDA, cutting four months off the standard 10-month review timeline. This time discount can make the difference between being the first to market and being a "me-too" drug, thereby making PRVs a prized and highly valuable asset for biopharmas.
There were 14 PRVs issued by the end of 2017. Sanofi SA used one that partner Regeneron Pharmaceuticals Inc. had bought from BioMarin Pharmaceutical Inc. for $67.5 million to get U.S. approval of Praluent (alirocumab) a month before Amgen Inc.'s Repatha (evolocumab). Gilead Sciences Inc. has a PRV that it bought from Sarepta Therapeutics Inc. for $125 million tucked in its back pocket. GlaxoSmithKline plc and ViiV Healthcare used one they purchased for $130 million from an undisclosed source to speed up the regulatory process for an HIV combination treatment that paired GSK's Tivicay (dolutegravir) and Johnson & Johnson's Edurant (rilpivirine).
Price tags on PRVs don't appear to be as high as they once were, perhaps because greater availability. In May 2015, Retrophin Inc. sold its voucher to Sanofi SA for $245 million, and then in August 2015, AbbVie Inc. handed over $350 million to United Therapeutics Corp. for a PRV.