AbbVie submits migraine prevention drug to EMA for marketing authorisation

AbbVie has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for atogepant as a migraine treatment for adults who have at least four migraine days per month.

Atogepant is an oral calcitonin gene-related peptide (CGRP) inhibitor. If approved, it would be the first daily oral CGRP receptor antagonist migraine treatment for adults in Europe.

Migraine is a complex neurological disease, affecting more than one billion people worldwide, including an estimated 11.4% of the population in Europe. The exact cause of migraines is unknown, although they are thought to be the result of temporary changes in the chemicals, nerves and blood vessels in the brain.

Episodic migraine is characterised by those with migraine who have zero to 14 headache days per month, while chronic migraine is characterised by 15 or more per month.

Michael Gold, therapeutic area head, neuroscience development, AbbVie, said: “Far too many people around the world are impacted from the debilitating challenges of migraine, which places a significant social and work-life burden for patients and care partners… If approved, atogepant will provide a prophylactic treatment option for adult migraine patients suffering for more than four days a month.”

The application is supported by positive data from the company's two phase 3 studies evaluating the safety, efficacy and tolerability of atogepant in adult patients with episodic migraine and chronic migraine.

Both the phase 3 PROGRESS and ADVANCE studies met their primary endpoints of a statistically significant reduction in mean monthly migraine days compared to placebo over a 12-week treatment period. In both studies, all doses were well tolerated, and the overall safety profiles were consistent with safety findings observed in previous studies for the prevention of episodic migraine and chronic migraine populations.

Atogepant is an orally administered, CGRP receptor antagonist developed for the prevention of migraines. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks, with selective CGRP receptor antagonists demonstrating clinical benefit in migraines.

Atogepant was approved as Qulipta in the US in September 2021 for the preventive treatment of episodic migraine in adult patients, making it the first CGRP receptor antagonist for this specific indication.