AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention

TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month1 Atogepant met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy1 Full results from the TEMPLE study will be presented at an upcoming medical meeting , /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.1 The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).1 The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001).1 "These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease." Migraine continues to be underdiagnosed and undertreated, despite significant burden on patients' lives.2 It is a complex neurological disease that affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide.2 Despite its prevalence and disabling impact, there are numerous gaps in patient care related to the standards for preventive treatment. Notably, over 50% of people currently using preventive medications still qualify for further preventive treatment, indicating that their current therapies may not be providing sufficient relief.3 "Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options," said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. "The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention." The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.1 Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. Atogepant is a once-daily oral CGRP receptor antagonist, proven to prevent both episodic and chronic migraine in adults.Full results from the TEMPLE study will be presented at an upcoming medical meeting. About the TEMPLE StudyTEMPLE is a Phase 3, multicenter, randomized, double-blind, active-controlled trial evaluating the tolerability, safety, and efficacy of atogepant versus topiramate in adult patients with a history of four or more migraine days per month. The trial randomized 545 participants with episodic or chronic migraine aged 18 and older across 73 sites in Europe, Israel and Canada. The study was conducted in two distinct periods. In the initial 24-week Double-Blind Treatment Period, which included a 6-week up-titration phase and an 18-week maintenance phase, participants were randomized to receive either atogepant (60 mg once daily) or the highest tolerated dose of topiramate (ranging from 50 to 100 mg/day). Following this, eligible participants continued into a 52-week Open-Label Treatment Period, during which all received atogepant (60 mg once daily). Throughout the study, patient reported outcomes were regularly collected and patients were continuously monitored for safety and tolerability through clinical assessments and lab tests. The primary endpoint was the percentage of patients who discontinued the study treatment due to AEs during the 24-week double-blind treatment period. An electronic diary (eDiary) was used to collect data on headache frequency, duration, symptoms, acute medication use, and various patient-reported outcomes. More information on the TEMPLE trial can be found on www.clinicaltrials.gov (NCT05748483). About Atogepant Atogepant is a once-daily orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks. Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. U.S. Uses and Important Safety Information What is QULIPTA® (atogepant)? QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION FOR QULIPTA®Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA. Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you: Have high blood pressure Have circulation problems in your fingers and toes Have kidney problems or are on dialysis Have liver problems Are pregnant or plan to become pregnant Are breastfeeding or plan to breastfeed Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines. QULIPTA can cause serious side effects, including: Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: swelling of the face, lips, or tongue; itching; trouble breathing; hives; or rash. High blood pressure: New or worsening of high blood pressure can happen. Contact your healthcare provider if you have an increase in blood pressure. Raynaud's phenomenon: A type of circulation problem can worsen or happen. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur. The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA. QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please see full Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in MigraineAt 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. In the United States, AbbVie is the only company with three prescription treatments designed to meet patient needs across the spectrum of migraine to help patients living with this debilitating disease. About AbbVieAbbVie's mission is to discover and deliver innovative medicines 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 – immunology, oncology, neuroscience, and eye care – 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 (formerly Twitter), and YouTube. Forward-Looking StatementsSome 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 2024 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. ALL-NEUR-250043 Contact(s): Global Media:Amber Landis+1 (231) 557-6596[email protected] U.S. Media:Sara Sanders+1 (973) 307-6145[email protected] References Data on file. AbbVie, Inc. ABVRRTI81148 Steiner TJ, Stovner LJ, Jensen R, et al. Migraine remains second among the world's causes of disability, and first among young women: Findings from GBD2019. The Journal of Headache and Pain.2020;21(1):137. https://doi.org/10.1186/s10194-020-01208-0 Buse DC, Sakai F, Matharu M, Reed ML, Fanning K, Dabruzzo B, Lipton RB. Characterizing gaps in the preventive pharmacologic treatment of migraine: Multi-country results from the CaMEO-I study. Headache. 2024;64(5):469-481. https://doi.org/10.1111/head.14721 SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention

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