CGRP Inhibitor Erenumab Gains EU Approval for Migraine Prevention

The once-monthly self-injected calcitonin gene-related peptide (CGRP) inhibitor is now approved in the European Union, Switzerland, the United States, and Australia.

Novartis and Amgen’s first-of-its-kind calcitonin gene-related peptide (CGRP) inhibitor ereunmab (Aimovig) has gained its fourth approval—this time in the European Union.

The European Commission green-lighted the migraine prevention treatment for adults who experience 4 or more migraine days per month and have previously failed on 2 to 4 previous treatments. Users can self-administer the autoinjector pen every 4 weeks. The CGRP inhibitor is now approved in the European Union, Switzerland, the United States, and Australia.

“Migraine matters. It is a painful, highly disruptive neurological disease that affects all aspects of life, from going to work to spending time with family and friends,” said Patrick Little, president, European Migraine and Headache Alliance, in a statement. “A treatment specifically designed for migraine prevention is a much-welcomed innovation and could transform lives of patients for whom current therapies do not work or are not well tolerated.”

According to Novartis, patients administered erenumab in clinical trials have reported consistent and sustained migraine prevention, with many experiencing a 50% or greater reduction in monthly migraine days. Safety and tolerability were comparable with that of placebo. An interim analysis from a 5-year open label extension in episodic migraine demonstrated that more than a quarter (26%) of patients taking 70 mg of erenumab were completely migraine-free.

“Erenumab heralds a new era in clinical practice, bringing both a targeted mechanism for prevention and a deep understanding of migraine, which we never had before,” said Petere Goadsby, MD, PhD, FRCP, director, NIHR-Wellcome Trust King’s Clinical Research Facility and professor of neurology at King’s College London, in a statement.

The EU approval comes just a few months after the FDA’s approval of erenumab for migraine prevention, making it the first CGRP inhibitor to be approved in the US. The approval followed positive results of the LIBERTY trial, which assessed the treatment in patients with episodic migraine. Patients taking erenumab had nearly 3-fold higher odds of having their migraine days reduced by at least 50%.

The list price totals $575 a month in the United States, or $6900 annually, which comes cheaper than previously expected. Analysts predicted the treatment would amount to $10,000 a year.

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