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AbbVie shares positive Phase 3 atogepant data to prevent chronic migraine

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AbbVieGepants have gained ground in recent years as a migraine treatment following the FDA’s approval of Allergan’s Ubrelvy (ubrogepant) in 2019.

Now, AbbVie (NYSE:ABBV) has announced that a Phase 3 study testing Qulipta (atogepant) met its primary endpoint of reducing mean monthly migraine days over placebo.

FDA approved atogepant as a preventive treatment of episodic migraine in adults on September 28, 2021.

The company hopes the data will convince FDA to authorize the expanded use of atogepant as a preventive treatment of chronic migraine.

AbbVie plans on filing a supplemental New Drug Application (sNDA) with the agency.

In the Phase 3 PROGRESS study, both the 60-mg once-daily and 30-mg twice daily versions of the oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met the endpoint over a 12-week treatment period.

In the study, 778 participants shared eDiary headache data. One treatment arm received the 60-mg once-daily ubrogepant, another the 30-mg twice-daily version, while the remaining third received placebo.

[Related: A neurologist dishes on the migraine treatment landscape]

Qulipta bottle

Qulipta bottle image courtesy of AbbVie

Patients getting the 60 version had a reduction of 6.88 average monthly migraine days, while those receiving the 30-mg version had a 7.46 reduction. Placebo recipients had a decrease in 5.05 monthly migraine days.

Recipients of atogepant also showed improvements in all secondary endpoints.

AbbVie also noted that the safety profile of the Progress study was in line with that of other studies.

“AbbVie has nearly 12 years of experience in treating chronic migraine, a debilitating disease. We know that no two migraine patients are alike, so it is important for health care providers to have a variety of treatment options,” said Dr. Michael Severino, vice chairman and president, AbbVie, in a news release.

Severino said the company plans on filing regulatory submissions to bolster its migraine portfolio.

AbbVie’s previous Phase 3 Advance study tested atogepant as a preventive episodic migraine treatment.

Filed Under: clinical trials, Drug Discovery, Neurological Disease
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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