ABBVIE INC. The overall long-term safety results were consistent with the known safety profile of atogepant in chronic and episodic migraine, and no new safety signals were identified. These results also support improvements in key efficacy outcomes, including reduction in monthly acute medication use days.
'Migraine is a debilitating neurological disease that can have a significant impact on day-to-day life,' said
The extension study included participants who had enrolled in the Phase 3 PROGRESS and ELEVATE clinical trials with a baseline monthly migraine day burden of 14.5 days and completed these studies. Key findings from the interim analysis include: Monthly migraine days improved on average by 8.5 days at Weeks 13-16 and this was consistent over 48 weeks. Similar improvements were observed for monthly headache days and monthly acute medication use days.
Seventy percent of subjects achieved 50% reduction in monthly migraine days at Weeks 13-16 and this was consistent during the 48 weeks of open-label treatment.
Overall safety results were consistent with the known safety profile of atogepant 60 mg, and no new safety signals were identified.
The most common treatment-emergent adverse events (5%) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).
'We understand that migraine is a complex disease and AbbVie is steadfast in our commitment to alleviating the considerable burden facing migraine patients,' said
Atogepant, also known as QULIPTA in the
AbbVie will continue to pursue additional regulatory submissions for atogepant across international markets.
About Study 3101-312-002
Study 3101-312-002 is an ongoing Phase 3, multicenter, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine. The primary objective was to evaluate safety and tolerability in all participants who received 1 dose of study intervention in the extension study (N = 595). Efficacy was evaluated by eDiary at Weeks 13-16, 29-32 and 45-48. The modified intention-to-treat population included participants who received 1 dose of atogepant and had 1 evaluable post-baseline 4-week period of eDiary data (N=524). Pre-specified efficacy endpoints included in the late-breaking data included change from baseline in monthly migraine days, monthly headache days, monthly acute medication use days and the proportion of participants with 50% improvement in monthly migraine days. The current interim analysis was performed after all study participants completed the efficacy data collection portion of the study at Week 52 or early termination.
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 have been failed by two to four classes of oral preventive 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 mean monthly headache days (MHDs), and change from baseline in acute medication use days across 12 weeks.
About the PROGRESS Study
The PROGRESS study was a global, randomized, double-blind, placebo-controlled Phase 3 trial assessing the efficacy, safety, and tolerability of atogepant for the preventive treatment of chronic migraine. Adults with a 1-year or longer history of chronic migraine were randomly assigned (1:1:1) to receive oral atogepant 30 mg twice a day (not a
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.
Atogepant, known as AQUIPTA in the
About Migraine and Chronic Migraine
Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea.1 It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in
People living with chronic migraine experience headaches or migraine for 15 or more days per month, with at least eight of those days associated with migraine.6 It is differentiated from episodic migraine, which is characterized by 0-14 headache days per month,7 by its more debilitating disease profile including greater prevalence of comorbid conditions as well as higher frequency of headache and migraine days.7-9 Individuals with chronic migraine experience frequent disabling migraine attacks, preventing them from performing daily activities and significantly affecting their quality of life. This results in substantial societal and familial burden.10-14 Significant direct and indirect costs are also associated with chronic migraine, leading to economic burden for patients and healthcare systems.15-17
About AbbVie in Migraine
AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine to help patients living with this debilitating disease.
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 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.
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.
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 2023 Annual Report on Form 10-K, which has been filed with the
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