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.