BioCentury
ARTICLE | Politics, Policy & Law

Tweaking PRVs

Tropical disease: Novartis shows FDA will honor vouchers; value still unclear

August 8, 2011 7:00 AM UTC

When Congress created the Priority Review voucher program in 2007, no one knew whether or how the reward scheme would succeed in stimulating the development of new therapies for neglected tropical diseases. Now a critical question - whether FDA will honor vouchers as Congress intended - has been answered affirmatively.

During the June 21 meeting of the Arthritis Advisory Committee, an FDA official revealed the sBLA for Ilaris canakinumab had been escalated from a standard to a priority review because Novartis AG had used a PRV to upgrade the review path...