- Phase 3 ADVANCE trial evaluating atogepant meets primary endpoint of statistically significant reduction from baseline in mean monthly migraine days, compared to placebo, for all doses evaluated across a 12-week treatment period

- Trial also demonstrates statistically significant improvements in all six secondary endpoints in the 30 mg and 60 mg once-daily treatment arms

- Data from this trial and previous Phase 2/3 trial will be the basis for regulatory submissions in the U.S. and other countries

- These results support AbbVie's commitment to providing multiple treatment options, including BOTOX® (onabotulinumtoxinA) for the prevention of chronic migraine and UBRELVY™ (ubrogepant), to treat migraine

NORTH CHICAGO, Ill., July 29, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses across the 12-week treatment period. With these results, combined with the prior positive Phase 2/3 trial, AbbVie plans to move forward with regulatory submissions in the United States and other countries. Full data results will be presented at an upcoming medical congress and/or published in a peer-reviewed journal.

"Migraine attacks can be debilitating, but migraine is a treatable disease, and people living with it are not alone in their battle to control it," said Thomas J. Hudson, M.D., senior vice president of R&D and chief scientific officer, AbbVie. "With the results from these trials, we aim to provide a safe and effective preventive treatment that offers patients and healthcare providers a simple, once daily oral treatment that works specifically by blocking CGRP receptors and preventing migraine."

About the Pivotal ADVANCE TrialThe pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the prevention of migraine in those with 4 to 14 migraine days per month. A total of 910 patients were randomized to one of four treatment groups evaluating 10 mg, 30 mg, or 60 mg of atogepant once daily, or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population of 873 patients.  

The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All atogepant dose groups met the primary endpoint and demonstrated statistically significantly greater decreases in mean monthly migraine days compared to placebo. Patients treated in the 10 mg/30 mg/60 mg atogepant arms experienced a decrease of 3.69/3.86/4.2 days, respectively, all compared to patients in the placebo arm, who experienced a decrease of 2.48 days (all dose groups vs. placebo, p=