Pfizer and Biohaven’s VYDURA® (Rimegepant) Receives First-Ever EC Approval for Dual Use in Acute Treatment and Prevention of Migraine in the EU

Compiled by Fan Dongdong

Recently, Vydura (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist jointly developed by Pfizer and Biohaven, has received marketing authorization from the European Commission (EC). It is approved for the acute treatment of migraine with or without aura, as well as for the preventive treatment of episodic migraine in adults who experience at least four migraine attacks per month. Vydura has also become the first drug in the EU to be approved for both the treatment and prevention of acute migraine.

Globally, migraine affects women three to four times more than men, with about one in ten people in Europe suffering from migraines. Nick Lagunowich, Global President of Pfizer Internal Medicine, stated that the treatment needs of those experiencing pain and disability due to frequent migraines have largely been unmet within the EU, while comprehensive clinical programs have confirmed the efficacy and safety of rimegepant for both acute and preventive treatment of migraines.

Previously published Phase 3 study results in The Lancet showed that, compared with placebo, a single dose of rimegepant alleviated pain and improved migraine-related symptoms within two hours. Another prevention study demonstrated that, compared with placebo, taking rimegepant every other day significantly reduced the number of monthly migraine days during weeks 9-12 of the 12-week treatment period, with sustained efficacy over a 12-month open-label extension period.

Rimegepant is a small-molecule oral calcitonin gene-related peptide (CGRP) receptor antagonist. It was launched in the United States in February 2020 as the first oral CGRP receptor antagonist approved by the U.S. FDA for the treatment and prevention of acute migraine attacks. In November 2021, Pfizer and Biohaven reached a cooperation agreement for two migraine drugs, rimegepant and zavegepant, granting Pfizer commercial rights in markets outside the United States in a deal worth up to $1.24 billion.

The final granting of the European marketing authorization for rimegepant follows the positive recommendation made by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in February. After receiving EU approval, the drug will be valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway, and will subsequently be included in local health insurance schemes. Currently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is also evaluating the marketing authorization application for rimegepant, with an approval expected in the UK shortly.

Reference Source: Pfizer and Biohaven’s VYDURA® (Rimegepant) Granted First Ever Marketing Authorization by European Commission for Both Acute Treatment of Migraine and Prophylaxis of Episodic Migraine