AbbVie (NYSE: ABBV) has revealed interim findings from an ongoing Phase 3 extension study, spanning 156 weeks, investigating the sustained safety and tolerability of oral atogepant for migraine prevention in individuals with chronic or episodic migraine. The analysis indicates that the long-term safety profile aligns with known data on atogepant in both chronic and episodic migraine, with no new safety concerns identified. Additionally, the results suggest notable enhancements in key efficacy measures, notably a reduction in monthly acute medication usage.
“Migraine poses significant challenges to daily functioning, underscoring the importance of effective preventive treatments,” remarked Dr. Sait Ashina, lead author of the study and Assistant Professor of Neurology and Anesthesia at Harvard Medical School. “This one-year atogepant data, particularly in chronic migraine patients, complements previous observations of its long-term safety and efficacy in the episodic migraine population, demonstrating its potential to mitigate migraine days and decrease acute medication dependency across the migraine spectrum.”
The extension study comprised participants from the Phase 3 PROGRESS and ELEVATE trials who had a baseline monthly migraine day burden of 14.5 days and had successfully completed these trials. Key interim findings include:
- An average improvement of 8.5 days in monthly migraine days at Weeks 13-16, sustaining over 48 weeks.
- Consistent enhancements observed in monthly headache days and monthly acute medication use days.
- Seventy percent of subjects achieving a ≥50% reduction in monthly migraine days at Weeks 13-16, a trend sustained throughout the 48-week treatment period.
- Overall safety outcomes remaining in line with the established safety profile of atogepant 60 mg, with no emergence of new safety signals.
- Common treatment-emergent adverse events (≥5%) included COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).
Dawn Carlson, Vice President of Neuroscience Development at AbbVie, emphasized the company’s dedication to addressing the substantial burden faced by migraine patients. She highlighted the significance of sustained safety and efficacy demonstrated in this interim analysis as a step forward in achieving migraine freedom.
Atogepant, marketed as QULIPTA® in the U.S. and AQUIPTA® in the European Union, holds approvals in 45 countries for the prevention of both episodic and chronic migraine in adults. AbbVie intends to pursue further regulatory clearances for atogepant across global markets.
About the Studies: The ongoing Phase 3 extension study (Study 3101-312-002) aims to assess the long-term safety and tolerability of oral atogepant in migraine prevention among participants with chronic or episodic migraine. The study’s primary objective is to evaluate safety and tolerability in all participants who received at least one dose of the study intervention in the extension phase. Efficacy assessments are conducted via eDiary at specified intervals. For more details, refer to ClinicalTrials.gov (NCT04686136).
The ELEVATE study was a global, randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and efficacy of atogepant 60 mg once daily for the preventive treatment of episodic migraine.
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.
About Atogepant (QULIPTA®): Atogepant, an orally administered CGRP receptor antagonist, is specifically developed for the preventive treatment of migraine in adults. Its efficacy is attributed to its ability to modulate CGRP levels, which are implicated in migraine pathophysiology.
Atogepant, known as AQUIPTA® in the European Union, received approval from the European Commission in August 2023 for the prevention of episodic or chronic migraine in adults experiencing four or more monthly migraine days.
IMPORTANT SAFETY INFORMATION:
- Patients should not take QULIPTA if they have had an allergic reaction to atogepant or any ingredients in the medication.
- Prior to initiating QULIPTA, patients should inform their healthcare provider about all medical conditions, including kidney or liver problems, pregnancy, or breastfeeding.
- Patients should disclose all medications, including prescription, over-the-counter, vitamins, and herbal supplements, to their healthcare provider, as QULIPTA may interact with certain medications.
- Serious allergic reactions, including anaphylaxis, may occur with QULIPTA. Patients experiencing symptoms such as swelling, itching, trouble breathing, hives, or rash should seek immediate medical assistance.
Common side effects of QULIPTA include nausea, constipation, and fatigue/sleepiness.
For full Prescribing Information, please visit the official website.
About Migraine and Chronic Migraine: Migraine is a neurological disorder characterized by recurrent, debilitating attacks, often accompanied by severe headache pain and other symptoms like sensitivity to light and sound. Chronic migraine entails headaches or migraines occurring on 15 or more days per month, with at least eight of those days fulfilling migraine criteria.
AbbVie in Migraine: AbbVie is committed to empowering individuals affected by migraine disease through a range of prescription treatments designed to address varying migraine needs.
About AbbVie: AbbVie is dedicated to discovering and delivering innovative medicines and solutions to tackle significant health challenges today and in the future, spanning various therapeutic areas including immunology, oncology, neuroscience, and eye care. For more information, visit www.abbvie.com.
Forward-Looking Statements: Certain statements in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied. AbbVie disclaims any obligation to update forward-looking statements. Please refer to the official release for further information.
