| - AQUIPTA® (atogepant) is now approved in the European Union for the acute treatment of migraine in adults, with or without aura, and for the prophylaxis of migraine in adults who have at least four migraine days per month.
- Approval was based on the pivotal Phase 3 ECLIPSE trial, which showed that AQUIPTA resulted in statistically significant pain freedom at two hours versus placebo during the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful and consistent effect across multiple migraine attacks.1
- The approval expands AbbVie's portfolio of migraine therapies for adult patients in the European Union, broadening treatment choices for those living with migraine.
NORTH CHICAGO, Ill., June 2, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved AQUIPTA® (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed (PRN). This approval is the second indication in the European Union for AQUIPTA, an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), which is now approved as both an acute treatment option for migraine attacks in adults and as a once-daily preventive treatment option for adults with chronic or episodic migraine who experience four or more migraine days per month. "The European Commission's approval of AQUIPTA is an important milestone for individuals requiring acute treatment for migraine. Clinical data have shown that AQUIPTA delivers fast and lasting relief for migraine attacks, including sustained pain freedom up to 48 hours," said Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. "With this approval, AbbVie is able to address unmet needs for those living with migraine in Europe, offering a broad portfolio of acute and preventive treatments for chronic and episodic migraine." Migraine is a prevalent and debilitating neurological disease, affecting roughly 14% of the global population,2 with a higher incidence in women than men.3 Especially common among individuals aged 25 to 55,4 migraine attacks can be characterized by severe, throbbing headaches, cognitive impairment, sensitivity to light and sound, and nausea, resulting in significant limitations on daily activities.5,6 Migraine is a leading cause of years lived with disability and profoundly affects quality of life.7 This debilitating disease also imposes both a social and financial burden for people living with migraine and on health care systems.8 According to recent 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 both paid and unpaid work.*9 "Migraine is an invisible disease that disrupts daily life, including meaningful time with friends and family, while also imposing significant mental, physical, and socioeconomic burdens," said Uwe Reuter, M.D., Ph.D., MBA, professor of neurology at Charité University Hospital, Berlin, Germany, and president of the European Headache Federation. "The pivotal Phase 3 study showed that AQUIPTA is an effective acute treatment option for migraine, and getting the right treatment can help clinicians better address the burden of this disease in people living with migraine." The approval of AQUIPTA is supported by data from the Phase 3 ECLIPSE study, which evaluated the efficacy, safety, and tolerability of AQUIPTA (60 mg) versus placebo for the acute treatment of migraine for a single attack and the consistency of effect across multiple attacks in adults with a history of migraine, with or without aura.1 The study met its primary endpoint, demonstrating that AQUIPTA was superior to placebo in achieving pain freedom at two hours after treatment of the first migraine attack (p<0.0001).1 Additionally, the study demonstrated statistical significance versus placebo across several ranked secondary endpoints, including freedom from the most bothersome migraine symptom at two hours post-treatment, pain relief at two hours, reduced use of rescue medication within 24 hours, and sustained pain freedom from 2 to 48 hours (p<0.0001).1 AQUIPTA also demonstrated clinically meaningful and consistent effect across multiple migraine attacks. During the 16-week, placebo-controlled, double-blind treatment period, AQUIPTA's safety profile was generally consistent with that observed in its approved indication for the preventive treatment of migraine. The most common adverse events were nasopharyngitis and upper respiratory tract infection. AQUIPTA is also approved in the European Union as a once-daily CGRP receptor antagonist (gepant) for the prophylaxis (prevention) of migraine in adults with at least four migraine days per month. About the ECLIPSE Study1
ECLIPSE is a 24-week, Phase 3, multicenter, randomized, double-blind, placebo-controlled multiple-attack study with an open-label extension that enrolled 1,328 adults aged 18 to 75 years with migraine, with or without aura, who had two to eight moderate to severe migraine attacks per month in each of the three months before screening. The study was conducted across 149 sites in Europe, the United Kingdom, Japan, China, South Korea, and Taiwan. The primary endpoint was pain freedom at two hours after the first attack, while key secondary endpoints included absence of the most bothersome migraine symptom at two hours post-dose, pain relief at two hours, reduced rescue-medication use within 24 hours, and sustained pain freedom from 2 to 48 hours. Participants in the ECLIPSE study were randomized to four double-blind treatment sequences to treat four qualifying migraine attacks with moderate or severe headache intensity with single-dose atogepant (60 mg) or placebo during the 16-week double-blind period. The first attack (1:1 placebo-to-atogepant allocation) was the single attack used to evaluate the primary and 16 secondary efficacy endpoints. After treating four qualifying migraine attacks during the double-blind period, participants entered an open-label treatment period through the end of the study (until week 24) and treated migraine attacks with a single dose of atogepant (60 mg). More information on the ECLIPSE trial can be found at www.clinicaltrials.gov (NCT06241313). About AQUIPTA® (atogepant)
AQUIPTA® (atogepant) is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, approved in the European Union for both acute and preventive treatment of migraine in adults. For preventive treatment, AQUIPTA is taken once daily; for acute treatment, it is taken as needed (PRN). Atogepant is approved for migraine prophylaxis in more than 60 countries and is marketed as AQUIPTA in the EU and QULIPTA® in the U.S., Canada, Israel, and Puerto Rico. EU Indications and Important Safety Information about AQUIPTA®▼(atogepant) Indication
AQUIPTA (atogepant) is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month and for acute treatment of migraine with or without aura in adults. Important Safety Information Contraindications
AQUIPTA is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use
AQUIPTA is not recommended in patients with severe hepatic impairment. Serious hypersensitivity reactions, including anaphylaxis, dyspnoea, rash, pruritus, urticaria, and facial oedema, have been reported with use of AQUIPTA. Fertility, pregnancy and lactation
AQUIPTA is not recommended during pregnancy and in women of childbearing potential not using contraception. Pharmacokinetic data after single-dose administration showed minimal transfer of atogepant into breast milk. Effects on ability to drive and use machines
AQUIPTA has no or negligible influence on the ability to drive and use machines. However, it may cause somnolence in some patients. Patients should exercise caution before driving or using machinery until they are reasonably certain that AQUIPTA does not adversely affect performance. Adverse reactions
The most common adverse drug reactions during AQUIPTA studies were nausea (9%), constipation (8%), and fatigue/somnolence (5%). Most of the reactions were mild or moderate in severity. The adverse drug reaction that most commonly led to discontinuation was nausea (0.4%). Nausea (1.3%) was the most commonly reported adverse reaction for acute treatment. This is not a complete summary of all safety information. See AQUIPTA full summary of product characteristics (SmPC) atwww.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in Migraine
At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives. About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X, and YouTube. Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Contact(s): Global Media:
Amber Landis
+1 (231) 557-6596
amber.landis@abbvie.com Footnotes * This initiative was funded by AbbVie. All content was designed and delivered by WifOR. AbbVie has had no input into the content, management, preparation, or creation of these materials. References 1 AQUIPTA. Summary of Product Characteristics. AbbVie; 2026
2 Stovner, L.J., Hagen, K., Linde, M. et al. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain 23, 34 (2022). https://doi.org/10.1186/s10194-022-01402-2
3 Al-Hassany L, Haas J, Piccininni M, et al. Sex and Gender Differences in Migraine. Front Neurol. 2020;11:549038.
4 What is Migraine. The Migraine Trust. Available at: https://migrainetrust.org/understand-migraine/what-is-migraine. Accessed January 1, 2026.
5 Migraine headaches. Cleveland Clinic. Available at: https://my.clevelandclinic.org/health/diseases/5005-migraine-headaches. Accessed January 1, 2026.
6 Fernandes C, Dapkute A, Watson E, et al. Migraine and cognitive dysfunction: a narrative review. J Headache Pain. 2024;25(1):221. doi:10.1186/s10194-024-01923-y
7 Steiner TJ, Stovner LJ, Jensen R, et al. Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020;21(1):1375
8 Messali A, Sanderson JC, Blumenfeld AM, et al. Direct and indirect costs of chronic and episodic migraine in the United States: a web-based survey. Headache. 2016;56:306-322.
9 The socioeconomic burden of migraine: The case of 6 European Countries. Wif0r Institute. Available at: https://www.wifor.com/de/download/the-socioeconomic-burden-of-migraine-the-case-of-6-european-countries/?wpdmdl=358248&refresh=685c5ea88c24c1750884008. ALL-AQPA-260006  View original content:https://www.prnewswire.co.uk/news-releases/abbvie-announces-european-commission-approval-of-aquipta-atogepant-for-the-acute-treatment-of-migraine-in-adults-302787637.html
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