Originally posted on AbbVie.com
– 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
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.”