CHMP Recommends Pfizer, Biohaven’s Generic Drug for Migraine Attacks
In all studies, 75 milligrams of generic drug rimegepant was safe and well-tolerated with rates of adverse events similar to placebo.
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By - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently adopted a positive opinion for Pfizer and Biohaven’s generic drug to treat migraine attacks.
The European Commission will review the CHMP’s positive opinion of 75 milligrams rimegepant to prevent or treat adults with at least four migraine attacks per month. The drug’s approval would be valid in 37 EU member states and Iceland, Lichtenstein, and Norway.
If approved, rimegepant will be the first calcitonin gene-related peptide (CGRP) receptor antagonist in the EU and the only migraine medication approved for both acute and preventative 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,” Nick Lagunowich, global president of Pfizer Internal Medicine, said in the announcement.
“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,” Lagunowich continued.
CHMP based its positive opinion on results from three Phase 3 studies, a long-term, open-label safety study in the acute treatment of migraine, and a Phase 3 study with a one-year open-label extension to prevent migraines.
In all studies, rimegepant was safe and well-tolerated with rates of adverse events similar to placebo.
In November 2021, Pfizer and Biohaven agreed to commercialize rimegepant in markets outside of the US. Under the terms of the agreement, Pfizer holds commercialization rights outside of the US, while Biohaven continues to lead research and development globally and retains the US market.
Over one billion people suffer from migraines globally. The World Health Organization (WHO) classifies migraine as one of the ten most disabling medical illnesses.
A September 2020 GoodRx report found that although prices for migraine medications rose by 40 percent through 2017, they sharply declined at the beginning of 2018 and haven’t increased much since.
Rimegepant targets a root cause of migraine by reversibly blocking CGRP receptors, inhibiting the biologic cascade that results in a migraine attack. FDA approved the drug in February 2020 for the acute treatment of migraine and in May 2021 to prevent episodic migraines.
