People in the European Union are one step closer to gaining access to an additional treatment option for acute migraine headaches. 

In their April 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use issued a positive opinion supporting the expansion of Aquipta (atogepant, AbbVie) for acute treatment of migraine with or without aura in adults. 

The decision broadens the drug’s current indication — prophylaxis of migraine in adults with at least 4 migraine days per month — to also include treatment of acute migraine episodes.

Disease Context and Drug Mechanism 

Migraine affects approximately 14% of the global population, with higher incidence among women than men. The neurologic condition most commonly impacts adults aged 25-55 years and is characterized by severe, throbbing headaches, light and sound sensitivity, and nausea that significantly limit daily activities. Beyond physical symptoms, migraine presents substantial socioeconomic challenges globally, consistently generating higher economic burden than cardiovascular disease or diabetes. In Europe, migraine contributes to gross domestic product losses of 1.2%-2.0%, with women experiencing four to nine times greater productivity losses in unpaid work vs men.

Atogepant functions as an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist developed specifically for migraine management. CGRP and its receptors exist in nervous system regions linked to migraine pathophysiology, with studies revealing elevated CGRP levels during migraine episodes. 

Clinical Evidence 

The phase 3 ECLIPSE trial showed atogepant’s superiority over placebo for acute migraine treatment. In this 24-week study involving 1223 adults aged 18-75 years, participants with migraine history received either atogepant 60 mg or placebo for treating qualifying attacks. The trial enrolled individuals experiencing two to eight moderate to severe migraine episodes monthly.

The primary endpoint revealed that 24.3% of patients who received atogepant experienced freedom from pain at 2 hours post-dose in vs 13.1% receiving placebo (odds ratio, 2.36; results were statistically significant). Additionally, the first 12 of 16 key secondary endpoints reached statistical significance; one of these endpoints was freedom from most bothersome migraine symptoms at 2 hours after treatment. The safety profile during the 24-week period aligned with previous studies for migraine prevention, with no new safety signals identified. Common treatment-emergent adverse events during the study included nasopharyngitis and upper respiratory tract infection.

The drug is not recommended in people with severe hepatic impairment, during pregnancy or in women of childbearing potential not using contraception. The most common side effects with Aquipta include nausea, constipation, tiredness, somnolence, decreased appetite and decreased weight.

Next Steps 

Detailed recommendations for Aquipta’s use will appear in the Summary of Product Characteristics, which will be published on the EMA website in all official European Union languages following the European Commission’s decision on this variation. The medication remains under additional monitoring, meaning it receives more intensive surveillance than other medicines.