Biohaven Pharmaceuticals and Pfizer indicated Wednesday they have secured approval to market the anti-migraine drug Vydura in Europe.
The European Commission granted marketing authorization for the drug, which is also known as rimegepant, or the brand name Nurtec ODT outside Europe.
The latest authorization includes marketing the drug for both acute treatment and for prevention of migraine in adults.
The drug, a calcitonin gene-related peptide (CGRP) receptor antagonist, is an orally disintegrating tablet, and is the first medicine approved for treating and preventing migraine in the European Union.
Nick Lagunowich, global president, Pfizer Internal Medicine, said in an announcement, “There is a significant unmet need for people in the European Union living with the pain and disability caused by frequent migraines.”
“We have great confidence in the positive impact Vydura could have on people living with this debilitating condition in the EU,” he said.
The companies estimate that approximately one in ten people in Europe suffer due to migraines, which impact more than one billion worldwide.
According to the companies, a Phase 3 study showed a single dose provided “superior” pain reduction and associated migraine symptoms compared with a placebo. When taken every other day, participants also saw reduction in the number of days per month in which they suffered migraines.
The marketing authorization this week follows the recommendation for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use in February.
Earlier this year, Pfizer and Biohaven reached an agreement in which Pfizer obtained commercialization rights to rimegepant outside the United States. Biohaven continues to lead research and development globally and retains the U.S. market.
Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.
