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Tuesday, March 30, 2021

FDA Accepts AbbVie New Drug Application for Migraine Preventive

 - If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine[1]

- In the Phase 3 ADVANCE trial for the preventive treatment of migraine in adults with 4-14 migraine days, all active treatment arms of atogepant met their primary endpoint, and the 30 and 60 mg doses met all six secondary endpoints with statistical significance[1]

- Migraine is a debilitating neurological disease affecting 39 million people in the U.S.[2]

- The atogepant application demonstrates AbbVie's longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine

https://www.prnewswire.com/news-releases/us-fda-accepts-abbvies-new-drug-application-for-atogepant-for-the-preventive-treatment-of-migraine-301257758.html

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