Atogepant Gains European Approval as Acute and Preventive Migraine Therapy

The European Commission (EC) has approved atogepant (Aquipta; AbbVie) for the acute treatment of migraine in adults with or without aura, expanding the therapy’s label beyond its previously authorized preventive indication. The decision makes atogepant one of the few calcitonin gene-related peptide (CGRP) receptor antagonists approved in Europe for both the prevention and acute treatment of migraine.¹

The approval was supported by findings from the pivotal phase 3 ECLIPSE trial (NCT06241313), which demonstrated that a 60-mg dose of atogepant was superior to placebo in achieving pain freedom 2 hours after treatment of a migraine attack. Additional analyses showed statistically significant improvements in freedom from the most bothersome symptom, pain relief at 2 hours, reduced rescue medication use within 24 hours, and sustained pain freedom from 2 to 48 hours after dosing.

“The European Commission’s approval of AQUIPTA is an important milestone for individuals requiring acute treatment for migraine,” Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer at AbbVie, said in a statement.¹ “Clinical data have shown that AQUIPTA delivers fast and lasting relief for migraine attacks, including sustained pain freedom up to 48 hours.”

Migraine remains one of the most prevalent neurological disorders worldwide, affecting an estimated 14% of the global population and serving as a leading cause of disability among adults.¹ The disease is characterized by recurrent attacks of moderate-to-severe headache often accompanied by nausea, photophobia, phonophobia, and cognitive dysfunction, creating substantial personal and societal burden.¹

The ECLIPSE study represented a notable evolution for the therapy by evaluating atogepant as an acute treatment rather than a preventive medication. The global phase 3 trial enrolled 1,328 adults aged 18 to 75 years with migraine, with or without aura, who experienced 2 to 8 moderate-to-severe migraine attacks per month. Participants were randomized to receive atogepant 60 mg or placebo for treatment of qualifying migraine attacks during a 16-week double-blind period followed by an open-label extension.¹

Earlier topline findings from ECLIPSE reported that 24.3% of patients receiving atogepant achieved pain freedom 2 hours after treatment of the first migraine attack compared with 13.1% of those receiving placebo (OR, 2.36; 95% CI, 1.76-3.15; P <.0001). The trial also met its key secondary endpoint of freedom from the most bothersome migraine symptom at 2 hours post-dose.⁵

In addition to demonstrating efficacy during a single migraine attack, ECLIPSE showed clinically meaningful and consistent benefit across multiple attacks, an outcome that has become increasingly important as clinicians evaluate therapies for real-world migraine management.¹

Safety findings from ECLIPSE were consistent with previous studies of atogepant in migraine prevention. During the placebo-controlled portion of the trial, the most common adverse events were nasopharyngitis and upper respiratory tract infection, with no new safety signals identified.^1,5

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The newly approved indication builds upon atogepant’s established role as a preventive migraine therapy. The oral CGRP receptor antagonist was first approved by the FDA in September 2021 under the brand name Qulipta for the preventive treatment of episodic migraine in adults, based on results from the pivotal phase 3 ADVANCE trial (NCT02848326). In that study, once-daily atogepant significantly reduced monthly migraine days compared with placebo across all evaluated doses.^2,3

ADVANCE enrolled 873 patients with episodic migraine who were randomized to once-daily atogepant (10 mg, 30 mg, or 60 mg) or placebo for 12 weeks. Across all doses, atogepant significantly reduced mean monthly headache days compared with placebo, with decreases of 3.9, 4.0, and 4.2 days in the 10-, 30-, and 60-mg groups, respectively, versus 2.5 days with placebo (P <.0001 for all). These improvements corresponded to responder rates of 56%, 59%, and 61% across the atogepant groups, compared with 29% for placebo.

In April 2023, the FDA expanded the therapy’s label to include prevention of chronic migraine after positive findings from the phase 3 PROGRESS trial (NCT03855137). Patients treated with atogepant experienced significantly greater reductions in monthly migraine days than those receiving placebo, further establishing the therapy as a preventive option across the migraine spectrum.⁴

With the EC decision, atogepant is now approved in the European Union as both a once-daily preventive treatment for adults experiencing at least 4 migraine days per month and as an as-needed therapy for acute migraine attacks. The expanded label broadens treatment flexibility for patients and clinicians while further extending the role of CGRP-targeted therapies in migraine management.¹

REFERENCES
1. AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults. News release. AbbVie. June 2, 2026. Accessed June 2, 2026. https://news.abbvie.com/news/press-releases/abbvie-announces-european-commission-approval-of-aquipta-atogepant-for-the-acute-treatment-of-migraine-in-adults.htm
2. FDA Approves QULIPTA™ (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine. News release. AbbVie. September 28, 2021. Accessed June 2, 2026. https://news.abbvie.com/news/press-releases/fda-approves-qulipta-atogepant-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-preventive-treatment-migraine.htm
3. Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021;385(8):695-706. doi:10.1056/NEJMoa2035908.
4. U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. News release. AbbVie. April 17, 2023. Accessed June 2, 2026. https://news.abbvie.com/article_display.cfm?article_id=12576
5. AbbVie to Present Phase 3 ECLIPSE Data Demonstrating Atogepant (AQUIPTA®) Superiority Over Placebo in Achieving Pain Freedom for the Acute Treatment of Migraine at the 19th European Headache Congress. News release. AbbVie. December 1, 2025. Accessed June 2, 2026. https://news.abbvie.com/news/press-releases/abbvie-to-present-phase-3-eclipse-data-demonstrating-atogepant-aquipta-superiority-over-placebo-in-achieving-pain-freedom-for-the-acute-treatment-of-migraine-at-the-19th-european-headache-congress.htm