AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA®) for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure at the 2023 ...

• The Phase 3 ELEVATE study demonstrated atogepant is effective and well-tolerated for the preventive treatment of episodic migraine in people who previously failed two to four classes of conventional oral medications used for prevention
• The trial met its primary and secondary endpoints with results showcasing a significant reduction in mean monthly migraine days for those with episodic migraine taking atogepant 60 mg once daily compared to placebo across a 12-week period
• Data will be presented as part of an oral and poster presentation during the AAN Scientific Platform Session for Emerging Science

NORTH CHICAGO, Ill., April 21, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive data from its Phase 3 ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications. The results of the study demonstrated adult patients in the atogepant 60 mg once daily (QD) arm experienced a decrease of 4.20 days in their mean monthly migraine days (MMDs) across the 12-week treatment period, which was statistically significantly greater than the 1.85 day reduction observed in the placebo arm (p<0.0001). The data will be presented during the Emerging Science session on Tuesday, April 25, at the 2023 American Academy of Neurology (AAN) Annual Meeting taking place in Boston, Massachusetts.

"We understand that people living with migraine endure a chronic neurological disease and we are dedicated to providing them the best chance to live a life with less frequent migraines," said Dawn Carlson, vice president, neuroscience development, AbbVie. "The data presented at AAN underscores the important role of atogepant, not only as a treatment option for people living with episodic migraine but also for those whose previous treatments failed to help reduce the impact of migraine on their lives."

The ELEVATE study met all primary and secondary endpoints and demonstrated a statistically significant reduction in MMDs for those with episodic migraine taking atogepant 60 mg QD compared to placebo. The primary endpoint was the change from baseline in mean MMDs across 12 weeks and the secondary endpoints included achievement of more than 50% reduction in MMDs, change from baseline in MMDs, and change from baseline in acute medication use days across 12 weeks.

A total of 309 participants were enrolled and of these participants, 56% had previously failed two classes of oral migraine preventive medications and 44% had previous failed three or more classes, having discontinued them due to concerns with efficacy or tolerability. The results demonstrated atogepant 60 mg QD was well tolerated and the safety results were consistent with the known safety profile of atogepant. The most commonly reported (≥5% in any treatment arm) treatment-emergent adverse events (atogepant vs placebo, respectively) included constipation (10.3% vs 2.5%), COVID-19 (8.3% vs 9.6%), nausea (7.1% vs 3.2%), and nasopharyngitis (5.1% vs 7.6%).

"For those living with migraine, the path towards effective treatment can be a long and complex journey," said Prof. Patricia Pozo-Rosich, MD, PhD, Head of Neurology Section, Vall d'Hebron Hospital and Institute of Research, Spain. "The ELEVATE trial demonstrates atogepant as a once-daily oral treatment that can significantly reduce monthly migraine days across a lifelong disorder, allowing people to experience relief in their daily lives, including those who have previously been failed by other preventive migraine treatments."

Migraine is highly prevalent, affecting one billion people worldwide,¹ and is one of the highest causes of disability for people under 50 years of age.² Individuals with migraine experience frequent disabling migraine attacks, preventing them from performing daily activities and significantly affecting their quality of life.³ This debilitating disease imposes both a social and financial burden causing a significant burden for people living with migraine and healthcare systems.⁴

The U.S. Food and Drug Administration recently approved QULIPTA^® as the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist proven to prevent both episodic and chronic migraine in adults in the United States. AbbVie will continue to pursue regulatory submissions for atogepant across international markets throughout the year.

About the ELEVATE Study
The ELEVATE study was a global, randomized, double-blind, placebo-controlled trial assessing the safety, tolerability, and efficacy of atogepant 60 mg once daily (QD) compared with placebo for the preventive treatment of episodic migraine in adult participants who previously failed two to four classes of oral prophylactic treatments. The primary endpoint was the change from baseline in mean monthly migraine days (MMDs) across 12 weeks. Secondary endpoints included achievement of more than 50% reduction in MMDs, change from baseline in MMDs, and change from baseline in acute medication use days across 12 weeks. More information can be found on www.clinicaltrials.gov (NCT04740827). 

About Atogepant (QULIPTA^®)
Atogepant is an 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 and selective CGRP receptor antagonists confer clinical benefit in migraine. The use of atogepant in migraine is not approved in the United Kingdom or European Union and its safety and efficacy have not been evaluated.

U.S. Indications and Important Safety Information about QULIPTA^® (atogepant)

QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA.

Before taking QULIPTA^® (atogepant) tablets, tell your healthcare provider about all your medical conditions, including if you:

• Have kidney problems or are on dialysis
• Have liver problems
• Are pregnant or plan to become pregnant. It is not known if QULIPTA will harm your unborn baby
• Are breastfeeding or plan to breastfeed. It is not known if QULIPTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking QULIPTA

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 allergic (hypersensitivity) reactions, like anaphylaxis, that 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.

The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA.

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/myAbbVieAssist 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 Neuroscience
At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit www.abbvie.com.

About AbbVie
AbbVie'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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

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, and changes to laws and regulations applicable to our industry. 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 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.

References

¹ "The facts about migraine." Migraine Research Foundation. Available at: https://americanmigrainefoundation.org/resource-library/migraine-facts/. Accessed: January 17, 2023.

² Steiner, T.J., Stovner, L.J., Jensen, R., et al. "Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019." The J Headache Pain 21, 137 (2020). https://doi.org/10.1186/s10194-020-01208-0.

³ Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review. Cephalalgia. 2011;31:837-850.

⁴ 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.

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