Biohaven Pharmaceutical Holding Company Ltd, a biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Nurtec ODT (rimegepant 75 mg) for the preventive treatment of migraine. Nurtec 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 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.

Peter J. Goadsby, M.D., Ph.D., D.Sc., Professor of Neurology at the University of California, Los Angeles and King's College London, recipient of the 2021 Brain Prize for his groundbreaking research discovering the role of CGRP in migraine commented, "The US FDA approval of NURTEC ODT for the preventive treatment of migraine along with its acute treatment indication is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine. To have one medication patients can use to treat and prevent migraine will likely change the treatment paradigm for many of the millions of people who live with migraine."

Nurtec ODT, with its novel quick-dissolve tablet formulation, works by blocking the CGRP receptor, treating a root cause of migraine. With this targeted mechanism of action, Nurtec ODT provides a more complete, flexible treatment plan that gives people with migraine increased control of their disease.

Vlad Coric, M.D., chief executive officer of Biohaven noted, "This US FDA approval marks the beginning of a new era for migraine treatments, allowing the potential for healthcare professionals to prescribe, and patients to have, a single medication to treat and prevent migraine attacks. NURTEC ODT is dissolving the line between acute and preventive treatment. This groundbreaking approach to treating the full spectrum of migraine disease, from acute therapy to prevention, can have a significant impact in a patient's life by helping to decrease treatment plan complexity and reduce challenges with adherence and polypharmacy. At Biohaven, neuroinnovation is at the center of our focus and we are committed to finding and advancing paradigm shifting treatment options to help people with neurological diseases so they can live life without the burden of these illnesses."