Migraine treatment obtains marketing authorization from the European Commission

VYDURA has obtained marketing authorization from the European Commission for the acute treatment of migraine and the 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, both for 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 the acute and prophylactic treatment of migraine in the European Union (EU). According to the press release, around 1 in 10 people live with migraines in Europe alone. Migraines disproportionately affect women three to four times compared to men worldwide.

The marketing authorization follows the recommendation for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in February. The approval will be valid for the 27 EU Member States, as well as Iceland, Liechtenstein and Norway. Approval is expected to follow shortly in the UK.

“Today’s approval marks a huge step forward for patients in Europe living with migraine. Migraine is often overlooked and undertreated, resulting in significant disability with suboptimal patient care,” commented Professor Peter Goadsby, Director of the National Institute for Health and Care Research (NIHR) Clinical Research Center ) and Professor of Neurology at King’s College London. “VYDURA’s promising efficacy and favorable benefit-risk profile bring hope to people in need of new treatment options for migraine. This approval has the potential to advance the standard of care for migraine in the EU and hopefully improve the quality of life for many people living with the burden of this widespread neurological disease.

Source: Pfizer

About Antoine L. Cassell

Check Also

India records success with BP treatment and control

India’s hypertension control initiative, launched in 2018, has expanded to over 100 districts India’s hypertension …