The EU's First Migraine Drug With Both Curative/Preventive Action! Pfizer's Rimegepant Approved

Recently, Vydura (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist developed by Pfizer and Biohaven, received marketing authorization from the European Commission (EC) for the treatment of acute migraine with or without aura, and Prevention of adult-onset migraine headaches with at least 4 attacks per month. Vydura also became the first drug approved in the EU for the treatment and prevention of acute migraine.

Globally, migraine affects women three to four times more than men, and in Europe alone about one in 10 people suffer from migraines. Nick Lagunowich, global president of Pfizer Internal Medicine, said: "There is a largely unmet need for the treatment of people suffering from pain and disability due to frequent migraine headaches within the European Union, and the comprehensive clinical program confirms rimegepant as an acute and preventive treatment for migraine headaches. effectiveness and safety.

Results of a phase 3 study previously published in The Lancet showed that a single dose of rimegepant reduced pain and improved migraine-related symptoms within two hours compared to a placebo. Another prevention study showed that rimegepant, taken every other day, compared with placebo, significantly reduced the number of migraine days per month in patients during weeks 9-12 of the 12-week treatment period, and the 12-month open Treatment effects continued during the label extension period.

rimegepant is a small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonist, which was launched in the United States in February 2020. It is the first oral CGRP approved by the US FDA for the treatment and prevention of acute migraine attacks. receptor antagonists. In November 2021, Pfizer and Biohaven reached a cooperation agreement for two migraine drugs, rimegepant and zavegepant, to obtain commercialization rights outside the United States, with a total transaction value of up to $1.24 billion.

This time, rimegepant was finally approved for marketing in Europe, following the approval recommendation made by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in February. After the drug is approved by the EU, it will be effective in 27 EU member states, as well as Iceland, Liechtenstein and Norway, and will also be included in local health insurance. At present, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) is also evaluating the application for marketing authorization for rimegepant, which is expected to be approved in the UK soon.