CHMP recommends approval of Vydura for migraine.- Biohaven Pharma
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vydura (rimegepant)( Nurtec ODT in the US), from Biohaven Pharma, intended for the prophylaxis and acute treatment of migraine. Vydura will be available as 75 mg oral lyophilisate.
The active substance of Vydura is rimegepant, an analgesic which works as an antagonist of calcitonin gene-related peptide (CGRP).
The benefits of Vydura are pain relief in acute migraine and reduction in monthly migraine days in prevention trials. The most common side effect is nausea. The full indication is: Vydura is indicated for the acute treatment of migraine with or without aura in adults; preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month.
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