FDA Approves Biohaven’s Preventive Treatment for Episodic Migraine

Biohaven Pharmaceuticals has announced that FDA has approved NURTEC® ODT (rimegepant 75 mg) for the preventive treatment of adult patients with episodic migraine (e.g. those who experience less than 15 headache days per month.)

The 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, the company reports.

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 US 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,” the company states.

William “BJ” Jones, Biohaven’s Chief Commercial Officer, Migraine & Common Disease, talks about the development of NURTEC ODT in his 2021 Emerging Pharma Leader profile.