Biohaven migraine drug partnered with Pfizer lands twin European approvals


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Biohaven migraine drug partnered with Pfizer lands twin European approvals



Pfizer exited neuroscience drug research years ago, but the company still found a way to add a new neuro drug to its portfolio. An FDA-approved migraine drug from partner Biohaven Pharmaceuticals now has marketing authorizations in Europe, enabling the pharmaceutical giant to start capturing a share of the fast-growing product.

The two companies announced Wednesday that the European Commission has approved Biohaven drug rimegepant for both migraine prevention and the treatment of acute migraine pain. The European decisions match the approved indications for the drug in the U.S., where it is marketed under the name Nurtec. In Europe, the drug will be called Vydura.

The approvals in Europe are also a win for Pfizer. Last November, the pharma giant inked a deal for the right to commercialize rimegepant globally, with the exception of the U.S. where Biohaven retains rights. Pfizer paid $500 million up front, a combination cash and stock. It’s also on the hook to pay New Haven, Connecticut-based Biohaven up to $740 million in milestone payments plus royalties from its sales of the drug. The deal includes a second Biohaven migraine drug being developed in nasal spray and soft-gel formulations.

Rimegepant is part of a relatively new class of drugs that block calcitonin gene-related peptide (CGRP), a protein whose levels rise during a migraine attack. The first CGRP-inhibitors hit the market in 2018. These drugs from Amgen, Eli Lilly, and Teva Pharmaceutical are antibodies administered as injections. Rimegepant is a small molecule that was developed for more convenient oral dosing. Biohaven formulated the product as a tablet that dissolves quickly in the mouth.

Until the emergence of CGRP drugs, migraine drug research had been quiet since the 1990s when a class of drugs known as triptans reached the market. Those drugs come in oral formulations but they’re only approved for treatment of acute migraine pain. Meanwhile, Pfizer hasn’t been a player in neuroscience research since it exited the field in 2018, citing setbacks to its internal programs.

Injectable CGRP drugs marked the first innovation for migraine treatment in a generation. Oral CGRP are making the field even more competitive. Allergan’s tablet Ubrelvy became the first FDA-approved oral CGRP drug in 2019, a decision that covered the treatment of acute migraine. AbbVie acquired Allergan later that year; Ubrelvy generated $552 million in 2021 sales for the North Chicago company. A second drug AbbVie migraine pill, Qulipta, was approved last year for migraine prevention.

The FDA approved Biohaven’s tablet for the treatment of acute migraine in 2020 and for migraine prevention nearly a year ago. Biohaven reported $462.5 million in 2021 product sales, a more than 600% increase over the prior year. Pfizer now aims to replicate that growth in Europe.

“Studies in acute migraine demonstrated a rapid and long-lasting relief of migraine headache and other symptoms with a single dose, while the prevention study found a significant reduction in migraine attacks with every other day dosing,” Nick Lagunowich, global president, Pfizer internal medicine, said in a prepared statement. “We have great confidence in the positive impact Vydura could have on people living with this debilitating condition in the EU.”

The marketing authorization for rimegepant in Europe follows a European Medicines Agency recommendation in February supporting the drug’s approval. The European Commission decision covers all 27 European Union members, as well as Iceland, Lichtenstein, and Norway. The drug is also under regulatory review in the United Kingdom. Pfizer and Biohaven said a drug decision there is expected soon.

Photo: sinonimas, Getty Images


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