Looking to reach patients with a wide range of migraine symptoms in Europe, Pfizer and Biohaven are first on the scene with an oral CGRP drug approval.
Wednesday, the European Commission approved the partners’ med rimegepant—sold in the U.S. as Nurtec ODT—to both treat acute migraines with or without aura and to prevent episodic migraine in adults who suffer at least four attacks per month. Across the pond, the med will be sold under the Vydura moniker, Pfizer and Biohaven said Wednesday.
The drug, which comes in the form of an orally disintegrating tablet, is the first med approved in Europe to treat and prevent the crippling condition, Pfizer and Biohaven said.
The green light represents a threat to AbbVie's emerging migraine franchise comprising acute treatment Ubrelvy and prevention drug Qulipta, which are not yet available in Europe.
Biohaven in November recruited Pfizer to spearhead commercialization of Nurtec outside the U.S. With their forces combined, the companies aim to grow Nurtec ODT into a “massive global brand,” Biohaven CEO Vlad Coric said last year.
Some 10% of people in Europe suffer from migraines, the partners said. Globally, “migraine disproportionately affect women by three to four times compared to men,” the partners pointed out.
The bloc based its approval decision on phase 3 data that showed a single dose of Vydura offered “superior” pain reduction and curbed migraine symptoms after two hours versus placebo. Vydura ran through a prevention study, too, which showed the med slashed the number of migraines patients suffered each month when taken every other day.
The European Medicines Agency gave Vydura the thumbs-up back in February. The med’s European Commission approval, meanwhile, opens a path to market in all 37 EU member states plus Iceland, Lichtenstein and Norway.
Up next, Pfizer will be tasked with negotiating reimbursement deals in individual countries.
Elsewhere, a Vydura green light is looming in the U.K., where the country’s regulator is currently weighing the med’s marketing authorization application.
Stateside, Nurtec won approval back in early 2020 as an acute treatment for migraines. It nabbed its prevention nod in May. Since then, Nurtec has become the top prescribed med among patients trying new oral migraine therapies, Biohaven has said. As of January, the company had tallied more than 1,375,000 prescriptions since launch.
Nurtec sales reached $462 million last year.
AbbVie’s Ubrelvy, for its part, posted $552 million in sales last year. Qulipta didn't win an FDA approval until late September, so AbbVie hasn't yet disclosed sales figures for the new prevention medicine.