Vydura authorized by EC for migraine

The European Commission (EC) has granted marketing authorization for Vydura (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month, from Pfizer (NYSE: PFE) and Biohaven Pharmaceutical (NYSE: BHVN).

Vydura, an orally disintegrating tablet, is the first medicine approved for both acute and prophylactic treatment of migraine in the European Union (EU). Migraine is a leading cause of disability worldwide with approximately one in ten people living with the condition in Europe alone. Globally, migraine disproportionately affects women by three to four times compared to men.

“There is a significant unmet need for people in the European Union living with the pain and disability caused by frequent migraines,” said Nick Lagunowich, global president, Pfizer Internal Medicine. “The comprehensive clinical program has established Vydura’s efficacy and safety as both an acute and preventive treatment of migraine. Studies in acute migraine demonstrated a rapid and long-lasting relief of migraine headache and other symptoms with a single dose, while the prevention study found a significant reduction in migraine attacks with every other day dosing. We have great confidence in the positive impact VYDURA could have on people living with this debilitating condition in the EU,” he added.