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Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs

 
• By Bridget Silverman

US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.

Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copy space.
Approval with a PRV occurs on average 3.9 months quicker than for an NME or novel biologic receiving standard review.

As Novartis AG and Gilead Sciences Inc. illustrated with recent approvals for Beovu (brolucizumab-dbll) and Descovy (emtricitabine and tenofovir alafenamide), sponsors taking advantage of the US Food and Drug Administration's priority review voucher incentive program have a high rate of on-time, first-cycle approvals.

Approval with a priority review voucher (PRV) occurs an average of 3.9 months earlier than for a new molecular entity...

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