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 …