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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Specialty athletic retailer Foot Locker, Inc. reported Friday a second-quarter net profit that plunged from last year, hurt by a sales decline amid markdowns. Quarterly sales met Street estimates. The company also trimmed it adjusted earnings and sales growth guidance for the full-year 2022. Google's hundreds of employees have signed a petition sent to executives demanding extension of abortion care benefits to contract workers. The workers also called to halt donations given to anti-abortion politicians and to expand travel benefits. The petition, circulated by the Alphabet Workers Union, has been signed by over 650 employees at Google's parent company Alphabet Inc. Apple Inc. has released an emergency security update noting that some of its iPhones, iPads and Macs had certain vulnerabilities. The tech major said the flaws potentially allow full admin access to devices. The models affected by the issue include iPhone 6S and later models, several models of the newer iPads, and Mac computers running macOS Monterey and above. The flaws also affect the iPod Touch
Follow RTT