Pfizer pulled out of neuroscience drug research a few years ago, but the company still found a way to add a new neurodrug to its portfolio.FDA-approved migraine drug from partner Biohaven Pharmaceuticals now available Marketing authorization In Europe, the pharma giant is starting to grab a piece of the fast-growing product.
The European Commission has approved Biohaven’s drug rimegepant for the prevention and treatment of acute migraine headaches, the companies announced Wednesday. The European decision matches the drug’s approved indication in the United States, where it is marketed under the name Nurtec. In Europe, the drug will be called Vydura.
The European approval is also a win for Pfizer. last November, The pharma giant signed a deal to commercialize rimegepant globally, except in the United States where Biohaven reserves the right. Pfizer paid $500 million up front, including cash and stock. It also needs to pay New Haven, Connecticut-based Biohaven up to $740 million in milestone payments and royalties on sales of the drug. The deal includes a second Biohaven migraine drug in development for nasal spray and softgel formulations.
Rimegepant is a relatively new class of drugs that block calcitonin gene-related peptide (CGRP), a protein that increases in levels during migraine attacks. The first CGRP inhibitors were launched in 2018. The drugs, from Amgen, Eli Lilly and Teva, are antibodies given as injections. Rimegepant is a small molecule developed for more convenient oral administration. Biohaven makes this product into tablets that dissolve quickly in the mouth.
Before the advent of CGRP drugs, research on migraine drugs had been quiet since the introduction of a class of drugs called triptans in the 1990s. These drugs come in oral preparations, but are only approved to treat acute migraine headaches.Meanwhile, Pfizer has not been involved in neuroscience research since its inception quit In 2018, the field cited setbacks in its internal programs.
The injectable CGRP drug marks the first innovation in the treatment of migraine in a generation. Oral CGRP makes the field more competitive.Allergan’s tablet Ubrelvy becomes First FDA-approved oral CGRP drug In 2019, a decision to cover acute migraine treatment. Later that year, AbbVie acquired Allergan; Ubrelvy generated $552 million in 2021 sales for the North Chicago company. A second drug, AbbVie’s migraine drug Qulipta, was approved last year for migraine prevention.
this FDA approves Biohaven’s tablet for acute migraine in 2020 and for Migraine Prevention almost a year ago. Biohaven reported product sales of $462.5 million in 2021, an increase of more than 600% from the previous year. Pfizer now aims to replicate this growth in Europe.
Nick Lagunowich, Pfizer’s internal global president, said: “Acute migraine studies have shown that a single dose provides quick, durable relief from migraine and other symptoms, while prevention studies have found that every other day can significantly reduce migraine attacks.” , said in a prepared statement. “We are confident in the positive impact Vydura may have on people living with this debilitating disease in the EU.”
The marketing authorization of rimegepant in Europe follows the European Medicines Agency’s recommendation in February to support the drug’s approval. The European Commission’s decision covers all 27 EU member states, as well as Iceland, Liechtenstein and Norway. The drug is also under regulatory review in the UK. Pfizer and Biohaven said a drug decision is expected soon.
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