Aquipta Approved in the EU as Preventive for Chronic and Episodic Migraine
Aquipta (atogepant; AbbVie, North Chicago, IL) was approved by the European Commission for the prevention of episodic or chronic migraine in adults with 4 or more monthly migraine days (MMDs). Aquipta is a calcitonin gene-related peptide (CGRP) receptor antagonist, which is approved by the Food and Drug Administration (FDA) in the United States as Quilipta (atogepant; AbbVie, North Chicago, IL) for the preventive treatment of migraine in adults.
The approval is based on data from the ADVANCE (NCT03777059) and PROGRESS (NCT03855137) phase 3 clinical trials assessing efficacy, safety, and tolerability of Aquipta vs placebo for the prevention of migraine in adults. ADVANCE included 873 adult participants with episodic migraine, whereas PROGRESS included 755 adult participants with chronic migraine. In the ADVANCE study, participants received once-daily placebo or once-daily Aquipta at either 10 mg, 30 mg, or 60 mg doses for 12 weeks. In the PROGRESS study, participants received either twice-daily placebo, twice-daily Aquipta at 30 mg, or once-daily Aquipta at 60 mg. In both trials, the primary outcome was change in MMDs determined from an analysis of data retrieved from patient-recorded diaries.
The primary endpoint was met in both trials with greater reduction in MMDs for Aquipta vs placebo. In PROGRESS, participants taking Aquipta 30 mg twice-daily and 60 mg once-daily experienced a mean change of -6.88 MMDs and -7.46 MMDs, respectively, compared to a -5.05 MMD mean change for placebo. In ADVANCE, participants receiving 10 mg Aquipta, 30 mg Aquipta, and 60 mg Aquipta experienced a mean change of -3.7 MMDs, -3.9 MMDs, and -4.2 MMDs, respectively, compared to a -2.5 MMD mean change in placebo. All secondary outcomes favored Aquipta except for the Activity Impairment in Migraine-Diary (AIM-D) scores measured in ADVANCE. The most common adverse events in both studies were constipation, nausea, and fatique.
“The pivotal phase 3 studies demonstrated Aquipta provides significant and sustained reduction of mean monthly migraine days,” said Patricia Pozo-Rosich, MD, PhD, Head of the Neurology Section of Vall d’Hebron Hospital and Institute of Research. “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.”