AbbVie files sNDA to USFDA for Atogepant for chronic migraine treatment
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."
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