FDA clears preventive indication for Nurtec ODT
Biohavan’s Nurtec ODT has a new indication. The drug has received the Food and Drug Administration’s approval for the preventive treatment of migraine.
The product, first approved in February 2020 to treat acute migraine, is indicated for adult patients with episodic migraine — those who experience fewer than 15 headache days per month. The approved product label also was 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, the company said.
Nurtec ODT is approved for acute treatment in all eligible adult patients with migraine, regardless of the number of monthly migraine days.
The company noted that 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.
"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,” said Vlad Coric, Biohaven CEO.
Coric continued,“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."