Migraines Be Gone: AbbVie’s Atogepant Reduces Headache Frequency and Severity
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Migraine headaches can be reduced in frequency and severity by atogepant, an oral therapy developed by AbbVie, according to data presented at the American Headache Society’s (AHS) Annual Scientific Meeting, June 3-6.
“Atogepant, currently under review by the U.S. Food and Drug Administration (FDA), is an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant). If approved, it will be the first and only oral gepant specifically developed for the preventive treatment of episodic migraine,” Mitchell Mathis, M.D., VP, neuroscience, AbbVie, told BioSpace.
"Migraine is an often-debilitating disease that affects millions of people in the prime of their lives, which is why the significant advancements AbbVie has made in the development of preventive and acute treatment options are so important," Mathis said when making the announcement. "The data AbbVie is presenting at AHS span our full migraine portfolio and are a result of our ongoing commitment to drive progress for the migraine community."
Atogepant was featured in 10 of the abstracts AbbVie presented during the AHS meeting. The company presented a total of 23 abstracts (including 4 podium presentations) from its migraine portfolio.
Several of those abstracts reported data from the Phase 3 randomized, double-blind, placebo-controlled ADVANCE trial, which evaluated the effects of atogepant among participants who experienced between 4 and 14 migraine days per month. Here are the key takeaways:
- The number of migraines and headaches declined. Participants enrolled in the 10 mg, 30 mg, and 60 mg atogepant arms experienced a reduction in migraine and headache days across 12 weeks of treatment.
- The frequency of migraines was reduced for the majority of patients taking atogepant by at least 50% per month. Specifically, 55.6%, 58.7%, and 60.8% of patients in the 10 mg, 30 mg, and 60 mg atogepant arms, respectively, achieved a 50% or greater reduction in monthly migraine days. This is compared to 29.0% of patients receiving placebo who reported a 50% or greater reduction in monthly migraine days.
- Patients’ quality of life improved. The ADVANCE trial found that improvements in the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score were significantly greater with atogepant at all doses. They indicated 9.9-, 10.1-, and 10.8-point improvements at 10 mg, 30mg, and 60 mg doses of atogepant compared to placebo at week 12. MSQ v2.1 measures health-related quality of life impairments attributed to migraine for Role Function-Restrictive, Role Function-Preventive, and Emotional Function domains. A higher score indicates a lesser impact of migraine on daily activities.
- Patients were better able to perform daily activities. The ADVANCE trial demonstrated that atogepant significantly improved patients’ functioning in daily activities and reduced physical impairment as measured by these secondary endpoints:
- AIM-D Performance of Daily Activities. The Activity Impairment in Migraine-Diary (AIM-D) is an 11-item daily diary measure that assesses the impact of migraine on the performance of daily activities and physical impairment. Significant improvements in the mean monthly AIM-D Performance of Daily Activities domain score (compared to placebo) were observed for the 30 mg and 60 mg doses. Specifically, the impact of migraines on patients’ daily lives declined 2.5 points for those in the 30 mg dose and 3.3 points for those in the 60 mg dose. The AIM-D domain scores range between 0 to 100. Higher scores indicate greater impact of migraine, and score reductions from baseline indicate improvement.
- AIM-D Physical Impairment. Similar to the Performance of Daily Activities domain, the physical impairment domain in the AIM-D score showed statistically greater improvement for the 30 mg and 60 mg doses of atogepant compared to placebo. The impact of migraine on physical abilities declined by 2.0 points for those in the 30 mg dose group and 2.5 points for those in the 60 mg dose group.
Data also was reported from a 52-week open label trial of atogepant. It showed:
- Efficacy increased throughout treatment. Atogepant, administered in 60 mg once-daily doses during a 52-week open-label trial, reduced monthly migraine days, moderate/severe headache days, and acute medication use days. The rates of response based on mean monthly migraine days also increased over the course of the trial. Efficacy was observed early, was sustained throughout one year, and indicated an increase in efficacy with duration of treatment.
- No new safety concerns were identified. Results of the 52-week open label safety trial indicated that long-term once-daily use of atogepant 60 mg for the preventive treatment of migraine over one year demonstrated safety findings consistent with ADVANCE with no new safety concerns identified
AbbVie anticipates a regulatory decision in late Q3 2021 from the FDA.
The company also is investigating atogepant for the preventive treatment of chronic migraine. A global study is ongoing. “In the future, we plan to explore other patient populations that may benefit from atogepant,” Mathis noted.