AbbVie Eyes Regulatory Approval for Atogepant After Positive Phase III Migraine Study
AbbVie’s investigational migraine drug atogepant significantly reduced mean monthly migraine days across a 12-week course of treatment. The positive results set the stage for the company to seek regulatory approval of atogepant as a preventative against migraines.
Atogepant, an oral CGRP receptor antagonist, is an experimental migraine treatment AbbVie gained through its acquisition of Allergan. On Wednesday, AbbVie announced positive results from the Phase III ADVANCE trial evaluating the medication as a preventative drug for migraine in patients who experience between four and 14 migraines per month. Migraine attacks can be debilitating and impact about 12% of the population in the United States, including children. Globally, more than one billion people suffer from migraines.
In the late-stage study, atogepant 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. The primary endpoint was a 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. Full data results will be presented at an upcoming medical congress and/or published in a peer-reviewed journal, AbbVie said.
A key secondary endpoint measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. AbbVie said a majority of patients in each dosing group hit this goal during the trial. About 30% of placebo patients were able to achieve the 50% reduction, AbbVie said.
Additional secondary endpoints measured across the 12-week treatment period included change from baseline in mean monthly headache days, mean monthly acute-medication use days, and mean monthly performance of daily activities and physical impairment domain scores of the Activity Impairment in Migraine-Diary and change from baseline in the Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive domain score at week 12. The trial demonstrated that treatment with 30 mg and 60 mg doses resulted in statistically significant improvements in all secondary endpoints, while treatment with the 10 mg dose resulted in statistically significant improvements in four out of the six secondary endpoints.
The positive results in the ADVANCE trial come about two years after atogepant hit the mark in another significant study. In 2018, atogepant met primary endpoints across all doses and dose regimens in a Phase IIb/III trial. At the time, Allergan said atogepant showed a statistically significant reduction in monthly migraine days.
“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,” Thomas J. Hudson, senior vice president of R&D and chief scientific officer of AbbVie said in a statement. “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.”
In December, the U.S. Food and Drug Administration approved Allergan’s Ubrelvy (ubrogepant) for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. The approval marked the first time a medication in the class of oral calcitonin gene-related peptide receptor antagonists was approved for the acute treatment of migraine.
Earlier this year, Denmark-based H. Lundbeck A/S won approval for Vyepti, a preventative treatment for migraine.