August 25, 2015
A new record has been set for the price of Priority Review Vouchers (PRVs) awarded by the US Food and Drug Administration (FDA), with the sale of United Therapeutics’ PRV to AbbVie for US$350 million (News coverage). The acquisition of the voucher by AbbVie gives the company the opportunity to reduce the FDA review period from ten to six months. AbbVie has not yet disclosed which late-stage drug will benefit from the PRV, although speculation is mounting that they may use it to accelerate the approval of venetoclax, an anti-leukemia drug developed in partnership with Roche.
When the PRV system was originally proposed by David Ridley, Henry Grabowski and Jeffrey Moe in 2006 in their Health Affairs article Developing Drugs for Developing Countries, the worth of PRVs was estimated at $300 million. With the purchase of the PRV by AbbVie, that estimate has been surpassed, with the four (of six awarded) vouchers sold to date realising ever increasing prices. A little over a year ago, Sanofi and Regeneron Pharmaceuticals paid US$67.5 million to BioMarin Pharmaceuticals for their PRV, which has successfully been used to gain FDA approval for the PCSK9 cholesterol drug Praluent, ahead of Amgen’s competitor product. A few months later, Gilead Sciences went on to pay US$125 million to Knight Therapeutics for their PRV to advance the approval of Gileads’ new HIV drug, while Retrophin commanded $245 million from Sanofi when they sold their PRV earlier this year.
This news is encouraging at a time when Medicines Development for Global Health, in partnership with the Global Health Investment Fund and the World Health Organization Special Programme for Research and Training in Tropical Diseases, is working on the registration of moxidectin for the treatment of onchocerciasis, one of the PRV-eligible NTDs.