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VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.
Pfizer and Biohaven Pharmaceutical Holding Company announced on April 27, 2022 that the European Commission (EC) has granted marketing authorization for VYDURA (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, for both the treatment of migraine with or without aura and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month.
The medicine is an orally disintegrating tablet and is the first medicine to be approved for both acute and prophylactic treatment of migraine in the European Union (EU). According to the press release, approximately 1 in 10 people are living with migraines in Europe alone. Migraines disproportionally affects women by three to four times compared to men globally.
The marketing authorization follows the recommendation for approval by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in February. The approval will be valid for all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. Approval is expected to follow shortly in the United Kingdom.
“Today’s approval marks a huge step forward for patients in Europe who are living with migraine. Migraine is often overlooked and undertreated, resulting in substantial disability with suboptimal care for patients,” commented Professor Peter Goadsby, director of the National Institute for Health and Care Research (NIHR) Clinical Research Facility and Professor of Neurology at King’s College London. “VYDURA’s promising efficacy and favorable benefit-risk profile spark hope for people in need of new migraine treatment options. This approval has the potential to advance the standard of care for migraine in the EU and I am hopeful it will improve the quality of life for many people living with the burden of this prevalent neurological disease.”