The European Commission has approved AbbVie’s Aquipta as migraine prophylaxis for adult patients, making it the first daily oral treatment of its class to be approved in the EU for the prevention of both chronic and episodic migraines.

Several calcitonin gene-related peptide (CGRP) antibodies are administered subcutaneously or via intravenous infusions. But there is a preference among patients for oral therapies, says Dawn Carlson, vice president, Neuroscience Development at AbbVie, in an interview with Pharmaceutical Technology. Lundbeck’s CGRP antibody Vyepti (eptinezumab), is administered through intravenous infusions, while Amgen’s Aimovig (erenumab) is injected subcutaneously.

The approval of Aquipta is based on the results of the two Phase III studies—ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which both met their primary endpoint of a statistically significant reduction in mean monthly migraine days versus placebo, per the 17 August announcement.

In the PROGRESS trial, patients in the 60mg Aquipta cohort reported a 6.8-day reduction in mean monthly migraine days, while those on placebo experienced a 5.1-day reduction. Such a reduction represents a clinically meaningful change in the experience of patients who feel pain not just during the actual migraine attack, but also in the symptoms prior to the attack, explains Carlson. The studies’ secondary endpoints were equally meaningful, with decreases in headache days and medication use, she adds.

Also known as atogepant, Aquipta is a CGRP receptor antagonist (gepant). The US Food and Drug Administration (FDA) first approved the treatment for prophylactic use as an episodic migraine treatment in September 2021. In April 2023, AbbVie managed to expand the drug’s label to chronic migraines. While the drug’s European brand name is Aquipta, it is sold under the name Qulipta in Canada and the US.

Carlson says: “Now that we’ve received approval, AbbVie is committed to bringing these expeditiously to patients and we’re working with the appropriate country authorities and reimbursement agencies to bring these solutions as quickly as we can…But that will take some time.”

According to a GlobalData consensus sales forecast, Aquipta/Qulipta is projected to have global sales of $1.37bn in 2029.

Beyond the EU and countries where the drug was already approved, AbbVie is on the lookout for further expansion.

“We know that migraine is a global disease with over a billion patients suffering, and we are committed to exploring options in other countries. And that’s on a case-by-case basis, but we are looking at other areas to bring this forward because AbbVie is committed to finding solutions for patients suffering from migraine.”

Reference：https://www.pharmaceutical-technology.com/news/abbvie-win-migraine-prevention-drug-aquipta-europe/