25 February 2022 - Biohaven Pharmaceutical and Pfizer today announced that the CHMP of the EMA adopted a positive opinion for rimegepant, a calcitonin gene-related peptide receptor antagonist, recommending the 75 mg dose of rimegepant (available as an orally dissolving tablet) for marketing authorisation for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least four migraine attacks per month.
The CHMP positive opinion was based on the review of the results from three Phase 3 studies and a long-term, open-label safety study in acute treatment of migraine, and a Phase 3 study with a 1 year open-label extension in the preventive treatment of migraine. In these studies, rimegepant was safe and well-tolerated with rates of adverse events similar to that of placebo.