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AbbVie Files SNDA For Atogepant For Label Expansion

AbbVie (ABBV) announced it has submitted a supplemental New Drug Application for atogepant to the FDA to support the preventive treatment of chronic migraine in adults. The company noted that the submission is based on pivotal phase 3 PROGRESS chronic migraine study evaluating atogepant in adult patients that met primary endpoint.

Michael Gold, therapeutic area head, neuroscience development, AbbVie, said: "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."

Atogepant is marketed as QULIPTATM in the U.S. and is approved to treat adults with episodic migraine.

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