Biohaven and Pfizer Receive Positive CHMP Opinion for Migraine Treatment
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, recommending the 75 mg dose of rimegepant (available as an orally dissolving tablet) for marketing authorization 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’s positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve rimegepant, whose European Union (EU) trade name will be VYDURA™, will be made by the EC and would be valid in all 27 EU member states as well as in Iceland, Lichtenstein, and Norway. If approved, rimegepant will be the first oral CGRP receptor antagonist in the EU, and the only migraine medication approved for both acute and preventive treatment.
“This expression of confidence in rimegepant brings us closer to our goal of helping patients suffering from this debilitating neurological disease find appropriate treatment,” said Nick Lagunowich, Global President, Pfizer Internal Medicine. “Pfizer is proud to have a strong footprint in Europe, which will help bring this important potential new treatment option to millions of adults in Europe living with migraine.”
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.
“The recommendation for rimegepant marks an important milestone for the migraine community,” said Vlad Coric, M.D., Chief Executive Officer and Chairman of the Board of Biohaven. “Together with Pfizer, we are dedicated to helping patients and hope to provide rimegepant to patients in Europe soon, and eventually those worldwide, who are living with this debilitating disease, many of whom do not have satisfactory treatment options today.”
Earlier this year, Pfizer and Biohaven entered into an agreement for the commercialization of rimegepant. Under the terms of the agreement, Pfizer has commercialization rights to rimegepant in markets outside of the U.S. Biohaven continues to lead research and development globally and retains the U.S. market.