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.
Rimegepant targets a key component of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. A single, quick-dissolving tablet of 75 mg rimegepant provides fast pain relief, significant pain reduction and return to normal function, and has a lasting effect of up to 48 hours in many patients. Rimegepant is taken orally as needed, up to 18 doses/month to stop migraine attacks or taken every other day to help prevent migraine attacks and reduce the number of monthly migraine days. Rimegepant does not have addiction potential and was not associated with medication overuse headache or rebound headache in clinical trials.
More than one billion people worldwide suffer from migraine and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new treatments as more than 90 percent of people with migraine are unable to work or function normally during an attack.
CGRP Receptor Antagonism
Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. CGRP receptor antagonists work by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. This unique mode of action potentially offers an alternative to other agents, particularly for patients who have contraindications to the use of triptans or who have a poor response to triptans or are intolerant to them. CGRP signal-blocking therapies have not been associated with medication overuse headache (MOH) or rebound headaches which limit the clinical utility of other acute treatments due to increases in migraine attacks that result from frequent use.
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Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s Neuroinnovation™ portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute and preventive treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer’s disease, and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis.