AbbVie Secures EU Approval for AQUIPTA in Acute Migraine

The European Commission (EC) has approved AbbVie’s AQUIPTA® (atogepant) for the acute treatment of migraine in adults with or without aura. The decision expands the medicine’s role in the European Union, where it is already approved as a once-daily preventive therapy for adults with chronic or episodic migraine who experience at least four migraine days per month. With this approval, AQUIPTA becomes the first oral CGRP receptor antagonist in the EU approved for both acute and preventive migraine treatment.

Migraine Burden

Migraine affects approximately 14% of the global population and disproportionately impacts women, particularly those aged 25 to 55 years. Attacks can cause severe headache, nausea, sensitivity to light and sound, and cognitive impairment, often disrupting work, social activities, and quality of life. The disease also creates a substantial economic burden through healthcare costs and lost productivity.

Pivotal Phase 3 Data

The approval was supported by data from the Phase 3 ECLIPSE study (NCT06241313), a 24-week, multicenter, randomized, double-blind, placebo-controlled trial that included a 16-week double-blind treatment period. The study enrolled 1,328 adults aged 18 to 75 years with migraine, with or without aura, across 149 sites in Europe, the United Kingdom, Japan, China, South Korea, and Taiwan.

Atogepant met the study’s primary endpoint, demonstrating superiority to placebo in achieving pain freedom two hours after treatment of the first migraine attack (p<0.0001). The therapy also achieved statistical significance across multiple secondary endpoints, including freedom from the most bothersome symptom at two hours, pain relief at two hours, reduced rescue medication use within 24 hours, and sustained pain freedom from two to 48 hours after treatment (p<0.0001).

Investigators also reported clinically meaningful and consistent efficacy across multiple migraine attacks, supporting both rapid symptom relief and durable treatment benefit.

Safety Profile

During the 16-week placebo-controlled treatment period, the safety profile of atogepant remained consistent with that observed in its approved preventive indication. The most common adverse events were nasopharyngitis and upper respiratory tract infection. No new safety signals were identified.

Mechanism of Action

Atogepant belongs to the gepant class of medicines and works by blocking the calcitonin gene-related peptide (CGRP) receptor, a key pathway involved in migraine pathophysiology. The oral therapy can now be used both as a once-daily preventive treatment and as an acute therapy taken as needed during migraine attacks.

Clinical, Regulatory and Market Context

Roopal Thakkar, Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie, said the approval provides an important new treatment option for people who require rapid relief from migraine attacks, highlighting data showing sustained pain freedom lasting up to 48 hours.

Uwe Reuter, President of the European Headache Federation and Professor of Neurology at Charité University Hospital in Berlin, emphasized the significant personal and socioeconomic burden of migraine and welcomed the availability of an additional acute treatment option.

The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), reinforcing confidence in the clinical data supporting the application. The expanded indication strengthens AbbVie’s position in the growing CGRP-targeted migraine market by allowing AQUIPTA to address both acute and preventive treatment settings across the EU.

Reference

AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults