The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the calcitonin gene-related peptide receptor antagonist (CGRP) rimegepant (Vydura, Biohaven) for the acute treatment of migraine (with and without aura) in adults and the preventive treatment of episodic migraine in adults who experience at least four migraine attacks per month.
If approved, rimegepant will be the first oral CGRP receptor antagonist in the European Union (EU) and the only migraine medication approved for both acute and preventive treatment, Biohaven noted in a press release.
The CHMP positive opinion was based on results from three phase 3 studies and a long-term, open-label safety study in acute treatment of migraine, as well as a phase 3 study with a 1-year open-label extension in the preventive treatment of migraine.
In testing, rimegepant was associated with acute migraine pain relief and a reduction in monthly migraine days. The most common adverse event was nausea.
If approved by the European Commission (EC), rimegepant will be available as a 75-mg orally dissolving tablet, the panel said.
Detailed recommendations for rimegepant will be given in the summary of product characteristics, which will be published in the European public assessment report. It will also be made available in all official EU languages if marketing authorization is granted by the EC.
As reported by Medscape Medical News, the US Food and Drug Administration (FDA) approved rimegepant (tradename, Nurtec) for the acute treatment of migraine in 2020. The FDA added an indication for prevention in 2021.
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