Pfizer and Biohaven Get EU Nod for Vydura Migraine Drug
The European Commission has granted a marketing authorization for Pfizer’s and Biohaven Pharmaceutical’s oral migraine drug Vydura (rimegepant).
The calcitonin gene-related peptide (CGRP) receptor antagonist is the first medicine approved for both acute and prophylactic treatment of migraine in the EU.
In a phase 3 study, patients given Vydura showed meaningful reductions in pain-associated symptoms of migraines after two hours compared with placebo. The drug also reduced the number of days per month with migraine in the 12-week treatment period compared to placebo.
Vydura, which is marketed as Nurtec ODT in the U.S., was first approved by the FDA in February 2020.
About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with proven leadership in industry and academic settings. Portfolio is comprised of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, including rare disorders. Progress is fueled by an entrepreneurial organizational structure and an impressive range of experience in drug development along with the confident support of top-tier biopharma investors. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital.
April 28, 2022
