North Chicago, Ill.: AbbVie has announced that the company has submitted a supplemental New Drug Application (sNDA) for atogepant (QULIPTA) to the U.S. Food and Drug Administration (USFDA) to support the preventive treatment of chronic migraine in adults.
If approved, atogepant (QULIPTA) would be the first gepant (oral calcitonin gene-related peptide [CGRP] receptor antagonist) approved for the broad indication of the preventive treatment of migraine, including episodic and chronic. The sNDA submission includes data from the pivotal Phase 3 PROGRESS trial in patients with chronic migraine, which supplements the existing data in episodic migraine. People living with chronic migraine experience headaches for 15 or more days per month, which, on at least eight of those days per month, have the features of migraine.
“Having one oral medication to treat both episodic and chronic migraine would be an important advancement for health care providers and patients,” said Michael Gold, M.D., therapeutic area head, neuroscience development, AbbVie. “This sNDA approval would also diversify AbbVie’s migraine portfolio and make it the only company to offer two approved preventive treatments for those living with chronic migraine. No two migraine patients are alike, so having multiple treatment options with unique mechanisms of action is critical.”
The pivotal Phase 3 PROGRESS trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period in adults with chronic migraine. The trial also demonstrated that treatment with atogepant 60 mg once daily (QD) and 30 mg daily (BID) resulted in statistically significant improvements in all six secondary endpoints. This includes a key secondary endpoint that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period.
The overall safety profile of the Phase 3 PROGRESS study was consistent with safety findings observed in previous studies in an episodic migraine population.
Atogepant is marketed as QULIPTA in the United States and is FDA-approved to treat adults with episodic migraine. Use of atogepant for the preventive treatment of chronic migraine in the United States is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.