AbbVie Submits Supplemental NDA for Atogepant Label Expansion for Migraine Prevention

 Submission is based on pivotal Phase 3 PROGRESS chronic migraine study evaluating atogepant (QULIPTA^TM) in adult patients that met primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo

-       If approved, atogepant (QULIPTA) would be the first gepant (oral calcitonin gene-related peptide [CGRP] receptor antagonist) with a broad preventive treatment of migraine indication that expands treatment to patients with chronic migraine

-       Label expansion would make AbbVie the only company to offer two preventive treatments for those with chronic migraine, atogepant (QULIPTA) and onabotulinumtoxinA (BOTOX^®)

https://www.biospace.com/article/releases/abbvie-submits-supplemental-new-drug-application-to-u-s-fda-for-atogepant-qulipta-to-support-label-expansion-for-the-preventive-treatment-of-migraine/