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news.AbbVie has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for atogepant (Qulipta) to support the label expansion to treat chronic migraine in adults.
AbbVie files sNDA to FDA for atogepant to treat chronic migraine. Credit: AbbVie Inc. North Chicago, Illinois, U.S.A.
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Atogepant is an oral calcitonin gene-related peptide [CGRP] receptor antagonist (gepant) which has been specifically developed as the preventive migraine treatment.
In September last year, the drug received FDA approval as a preventive treatment of episodic migraine in adults.
The company’s sNDA submission includes data obtained from the pivotal Phase III PROGRESS trial which was conducted to evaluate oral atogepant’s efficacy, tolerability, and safety to prevent chronic migraine.
The study met its primary endpoint, which is related to a statistically significant reduction from baseline in mean migraine days per month compared to placebo, across the 12-week treatment period.
Furthermore, subjects treated with 60mg atogepant once daily (QD) and 30mg daily (BID) reported statistically significant improvements in all six secondary endpoints.
AbbVie neuroscience development therapeutic area head Michael Gold said: “Having one oral medication to treat both episodic and chronic migraine would be an important advancement for health care providers and patients.
“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.”
If approved, atogepant will become the first gepant approved to find use as a broad preventive treatment of migraine that includes treatment for episodic and chronic migraine.
