AbbVie has secured a significant regulatory milestone in Europe after the European Commission approved AQUIPTA® (atogepant) for the acute treatment of migraine in adults, providing patients with a new oral therapy that can be taken as needed to relieve migraine attacks.
The decision expands the use of AQUIPTA in the European Union and marks the second approved indication for the medicine. The drug was already authorized as a preventive treatment for adults with chronic or episodic migraine who experience at least four migraine days per month. With the latest approval, AQUIPTA becomes one of the few therapies in Europe approved for both the prevention and acute treatment of migraine.
AQUIPTA belongs to a class of medicines known as calcitonin gene-related peptide (CGRP) receptor antagonists, or gepants. These therapies target the CGRP pathway, which plays a key role in the development of migraine attacks. By blocking CGRP receptors, the medication is designed to reduce migraine symptoms without causing the blood vessel constriction associated with some older migraine treatments.
The approval is supported by data from the pivotal Phase 3 ECLIPSE clinical trial, which evaluated the efficacy, safety, and tolerability of a 60 mg dose of AQUIPTA compared with placebo in adults with a history of migraine, with or without aura. The study assessed the treatment’s ability to relieve symptoms during a single migraine attack as well as its consistency across multiple attacks.
Results showed that AQUIPTA met its primary endpoint, demonstrating a statistically significant improvement over placebo in achieving complete pain freedom two hours after treatment of the first migraine attack. Researchers also reported significant benefits across several secondary endpoints, including freedom from the most bothersome migraine symptom, pain relief at two hours, reduced need for rescue medication within 24 hours, and sustained pain freedom for up to 48 hours after treatment.
According to AbbVie, the therapy also demonstrated a consistent effect across multiple migraine episodes, highlighting its potential as a reliable treatment option for patients who experience recurring attacks.
Migraine remains one of the most common neurological disorders worldwide, affecting an estimated 14% of the global population. The condition disproportionately impacts women and is particularly prevalent among adults between the ages of 25 and 55. Migraine attacks can involve severe throbbing headaches, nausea, sensitivity to light and sound, and cognitive difficulties, often interfering with work, family life, and daily activities.
The disease also carries a substantial economic burden. Recent analyses across several European countries suggest migraine contributes significantly to lost productivity and healthcare costs, with the total economic impact estimated to range from tens to hundreds of billions of euros annually.
Roopal Thakkar, Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie, said the approval represents an important advancement for people seeking effective acute migraine treatment. He noted that clinical studies demonstrated both rapid and durable relief, including sustained pain freedom for up to 48 hours following treatment.
Neurology expert Uwe Reuter, President of the European Headache Federation, described migraine as an often invisible disease that can have profound physical, emotional, and socioeconomic consequences. He said access to effective acute treatments can help physicians better manage the burden of the condition and improve quality of life for patients.
During the 16-week placebo-controlled treatment period in the ECLIPSE study, AQUIPTA’s safety profile was generally consistent with previous clinical experience. The most commonly reported adverse events were nasopharyngitis and upper respiratory tract infections.
With the European Commission’s decision, AbbVie further strengthens its migraine portfolio and expands treatment options for millions of patients across Europe seeking both preventive and on-demand migraine care.