FDA Approves Expanded Indication for Atogepant to Prevent Chronic Migraine in Adults
The Food and Drug Administration (FDA) has approved expanding the indication of atogepant (Qulipta; AbbVie, Chicago, IL) 60 mg/d to include the preventive treatment of chronic migraine in adults. The expanded indication provides an additional treatment option for those with chronic migraine, a diagnosis for those who experience migraines at least 8 times per month for at least 3 months.
The expanded indication is based on results from the pivotal phase 3 PROGRESS trial (NCT03855137) which evaluated a 60 mg, once-daily dose in adult patients diagnosed with chronic migraine. Atogepant met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days (MMDs) compared to placebo across the 12-week treatment period, with a mean change of -7.27 of migraine days in the group assigned to receive the drug once daily. The trial also showed that treatment with atogepant was associated with improvements in secondary endpoints, including performance of daily activities, less activity impairment due to migraine, and overall quality of life measurements.
“The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe, and effective treatment option in a convenient, once-daily pill,” said Peter McAllister, MD, director, New England Center for Neurology and Headache. “Qulipta’s data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks.”
In 2021, the FDA approved atogepant, a calcitonin gene-related peptide receptor antagonist, for the treatment of episodic migraine. Atogepant is contraindicated in those with kidney or liver problems or in those who are pregnant or planning to become pregnant. The overall safety profile of atogepant is similar to side effects seen with treatment of episodic migraine with atogepant and includes constipation, nausea, and fatigue/sleepiness as the most common adverse events.