AbbVie announced that the European Commission has approved AQUIPTA (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed. The decision gives AQUIPTA a second indication in the European Union, where it is now authorized both as an acute treatment for migraine attacks and as a once-daily preventive option for adults with chronic or episodic migraine who experience at least four migraine days per month.
The approval is based on the pivotal Phase 3 ECLIPSE trial, which evaluated AQUIPTA 60 mg versus placebo for the acute treatment of migraine in adults with a history of migraine, with or without aura. The study met its primary endpoint, showing that AQUIPTA was superior to placebo in achieving pain freedom at two hours after treatment of the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful, consistent effect across multiple attacks. The trial also showed statistically significant benefits over placebo on several secondary endpoints, including freedom from the most bothersome symptom at two hours, pain relief at two hours, reduced use of rescue medication within 24 hours, and sustained pain freedom from 2 to 48 hours.
During the 16‑week, placebo-controlled, double‑blind period, the safety profile of AQUIPTA was generally consistent with its use in migraine prevention, with nasopharyngitis and upper respiratory tract infection reported as the most common adverse events. AbbVie said the new indication broadens its migraine portfolio for adults in the EU, expanding treatment choices for people living with migraine.
Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer at AbbVie, said the approval represents an important milestone for patients needing acute migraine treatment and noted that clinical data show fast and lasting relief, including sustained pain freedom up to 48 hours. Uwe Reuter, M.D., Ph.D., MBA, professor of neurology at Charité University Hospital in Berlin and president of the European Headache Federation, said migraine is an “invisible” disease that disrupts daily life and carries significant mental, physical and socioeconomic burdens, and that the Phase 3 data support AQUIPTA as an effective acute treatment option.
Migraine is described as a prevalent and debilitating neurological disease affecting about 14% of the global population, with higher incidence in women and particular frequency in people aged 25 to 55. Attacks can involve severe throbbing headaches, cognitive impairment, sensitivity to light and sound, and nausea, leading to substantial limitations in daily activities. Migraine is a leading cause of years lived with disability and imposes social and financial burdens on patients and health systems; an analysis from six European countries estimated that migraine accounts for 1.2% to 2.0% of gross domestic product, equivalent to €35 billion to €557 billion in lost productivity from paid and unpaid work.
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