Gepants 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.
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