FDA APPROVES BIOHAVEN'S NURTEC® ODT (RIMEGEPANT) FOR PREVENTION: NOW THE FIRST AND ONLY MIGRAINE MEDICATION FOR BOTH ACUTE AND PREVENTIVE TREATMENT

发布时间： 2021-05-31 阅读：501次

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May 27, 2021 -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that the U.S. Food and Drug Administration (FDA) has approved NURTEC® ODT (rimegepant 75 mg) for the preventive treatment of migraine. 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. 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.

Vlad Coric, M.D., Chief Executive Officer of Biohaven noted, "This 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. "