Benzinga | May 27, 2021 04:17PM EDT

Biohaven Announces FDA Approval Of NURTEC ODT

Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN), today announced that the U.S. Food and Drug Administration (FDA) has approved NURTEC(r) ODT (rimegepant 75 mg) for the preventive treatment of migraine. NURTEC(r) ODT is indicated for adult patients with episodic migraine, e.g. those who experience less than 15 headache days per month. The approved product label was also expanded to include the use of NURTEC ODT 75 mg up to 18 doses/month, allowing for both acute and preventive therapy in the same patient. This new approval makes NURTEC ODT the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment. NURTEC ODT is approved for acute treatment in all eligible adult patients with migraine, regardless of the number of monthly migraine days. Since approximately 95% of all U.S. migraine patients experience less than 15 headache days per month, the new indication of preventive treatment significantly expands the market potential of NURTEC ODT and provides a new preventive treatment option for the vast majority of people living with migraine.