AbbVie has received the European Commission (EC) approval for Aquipta (atogepant) to prevent or prophylaxis of migraine in adults who have four or more migraine days per month.

Atogepant is an orally administered, calcitonin gene-related peptide CGRP receptor antagonist.

CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology.

Atogepant is approved in the US for both chronic and episodic migraine, and in Canada for episodic migraine under the brand name QULIPTA.

With the EC approval, Aquipta is the first and only once-daily oral CGRP receptor antagonist for the preventive treatment of both chronic and episodic migraine, in the European Union (EU).

AbbVie development and regulatory affairs SVP, chief medical officer Roopal Thakkar said:  “The EC approval of Aquipta is a significant milestone for people suffering from four or more migraine days per month as it provides a once-daily treatment option that can reduce the number of migraine days and the associated pain they experience.

“With this approval, AbbVie can help meet additional migraine patient needs through our enhanced portfolio of treatment options across migraine frequencies, including episodic and chronic migraine.”

The EC approval of Aquipta is based on data from two Phase 3 studies, PROGRESS, and ADVANCE, which evaluated Aquipta 60mg in chronic migraine and episodic migraine.

In both studies, Aquipta resulted in a statistically significant reduction in mean monthly migraine days (MMDs) compared to placebo, the primary endpoint.

In addition, the dug also statistically significant improvements were seen in all secondary endpoints, including patients achieving at least a 50% reduction in MMDs in 12 weeks.

The PROGRESS study showed that 40% of patients treated with Aquipta 60mg achieved at least a 50% reduction in MMDs, compared to 27% in the placebo arm.

Also, the ADVANCE study showed that 59% of patients treated with Aquipta 60mg achieved at least a 50% reduction in MMDs, compared to 29% of patients in the placebo arm.

In both studies, Aquipta 60mg was well tolerated, with the most common adverse events being constipation, nausea, and fatigue, said the US drugmaker.

Vall d’Hebron Hospital and Institute of Research neurology section head Patricia Pozo-Rosich said: “Migraine is a neurological disease that causes recurrent pain and other migraine-associated symptoms, with attacks that can last several hours to days, leading to missed life opportunities.

“The pivotal Phase 3 studies demonstrated AQUIPTA provides significant and sustained reduction of mean monthly migraine days.

“This allows people to experience relief with a simple to take once-daily tablet, including those who have had an insufficient response to prior preventative migraine treatments.”