EU approves Aquipta for prophylaxis of migraine – AbbVie

AbbVie announced that the European Commission has approved Aquipta (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. The approval makes Aquipta the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment in the European Union for the preventive treatment of both chronic and episodic migraine.

The approval of Aquipta is supported by data from two pivotal Phase III studies, PROGRESS and ADVANCE, which evaluated 60 mg once-daily (QD) Aquipta in adult patients with chronic migraine and episodic migraine, respectively. Both studies met their primary endpoint of a statistically significant reduction in mean monthly migraine days (MMDs), compared to placebo across the 12-week treatment period. Additionally, statistically significant improvements were seen in all secondary endpoints with Aquipta 60 mg QD, with a key secondary endpoint measuring the proportion of patients that achieved at least a 50% reduction in MMDs across the 12-week treatment period.

In the PROGRESS study, the changes from baseline in MMDs was a reduction of 6.8 days for Aquipta 60 mg QD and a reduction of 5.1 days for placebo (p=0.0024). The study demonstrated that 40% of patients treated with Aquipta 60 mg QD achieved at least a 50% reduction in MMDs, compared to 27% of patients in the placebo arm (p=0.0024). In the ADVANCE study, the changes from baseline in MMDs was a reduction of 4.1 days for Aquipta 60 mg QD and a reduction of 2.5 days for placebo (p=0.001). The study also demonstrated that 59% of patients treated with Aquipta 60 mg QD achieved at least a 50% reduction in MMDs, compared to 29% of patients in the placebo arm (p=0.0001).

In both studies, Aquipta 60 mg QD was well tolerated and the most common adverse events were constipation (8%), nausea (9%) and fatigue (5%). The adverse drug reaction most commonly leading to study discontinuation was nausea (0.4%).