Posted by Michael Wonder on 19 Mar 2019
Biohaven secures priority review voucher to expedite regulatory review of Rimegepant Zydis ODT new drug application
18 March 2019 - Rimegepant Zydis orally disintegrating tablet is Biohaven's lead oral CGRP receptor antagonist drug candidate from its Nojection migraine platform.
Biohaven Pharmaceutical Holding Company today announced that the company has purchased a U.S. FDA priority review voucher to use with the NDA submission of rimegepant Zydis ODT in the second quarter of 2019.
The voucher entitles the holder to designate a new drug application for priority review and provides for an expedited six month review.
