Benzinga | Oct 14, 2020 07:33AM EDT

FDA Accepts Biohaven's Supplemental New Drug Application Of NURTEC ODT For The Preventive Treatment Of Migraine

Acceptance marks critical milestone in Biohaven's efforts to develop NURTEC ODT as a unique dual therapy for both the preventive and acute treatment of migraine

NURTEC ODT 75 mg has been shown in placebo-controlled trials to return patients to normal functioning within 60 minutes when used in the acute treatment of migraine and has also been shown to reduce monthly migraine days at the same 75 mg dose administered every other day for preventive treatment

NURTEC ODT is the first CGRP-targeting agent to file for regulatory approval as a single medication to treat both acute episodes and prevent future migraine attacks

NEW HAVEN, Conn., Oct. 14, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review its recently submitted supplemental New Drug Application (sNDA) for NURTEC(tm) ODT (rimegepant) for the preventive treatment of migraine. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021.