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.