The European Commission has approved AQUIPTA (atogepant), an oral migraine medication manufactured by AbbVie, for acute treatment of migraine attacks in adults. This marks the second indication for the drug in the European Union, following its earlier approval for migraine prevention.
AQUIPTA is a calcitonin gene-related peptide (CGRP) receptor antagonist—a class of drugs that blocks a molecule involved in migraine pathways. The approval was based on the Phase 3 ECLIPSE trial, which studied 1,328 adults aged 18 to 75 years across 149 sites in Europe, the United Kingdom, Japan, China, South Korea, and Taiwan. Participants had two to eight moderate to severe migraine attacks monthly.
Trial Results
The ECLIPSE study met its primary endpoint, demonstrating that AQUIPTA (60 mg) was superior to placebo in achieving pain freedom at two hours after treatment of the first migraine attack (p<0.0001). The drug demonstrated sustained pain freedom from 2 to 48 hours and clinically meaningful effects across multiple migraine attacks. Secondary endpoints showed statistical significance versus placebo, including freedom from the most bothersome symptom at two hours post-treatment, reduced use of rescue medication within 24 hours, and consistent effects across multiple attacks.
During the 16-week placebo-controlled double-blind period, the safety profile was consistent with previous trials. The most common adverse events were nasopharyngitis and upper respiratory tract infection. Other common adverse reactions included nausea (9%), constipation (8%), and fatigue/somnolence (5%), with most mild or moderate in severity.
Disease Burden and Clinical Context
Migraine affects roughly 14% of the global population, with higher incidence in women than men and peak prevalence among those aged 25 to 55. According to analysis of six European countries, migraine contributes an estimated economic burden of 1.2% to 2.0% of GDP, corresponding to 35 billion to 557 billion in lost productivity from paid and unpaid work. Roopal Thakkar, AbbVie’s chief scientific officer, stated the approval addresses “unmet needs for those living with migraine in Europe.”
AQUIPTA is not recommended during pregnancy and in women of childbearing potential not using contraception. The drug may cause somnolence in some patients, and those should exercise caution before driving or using machinery until reasonably certain AQUIPTA does not adversely affect performance.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.prnewswire.com/news-releases/abbvie-announces-european-commission-approval-of-aquipta-atogepant-for-the-acute-treatment-of-migraine-in-adults-302787637.html