FDA Approves Expanded Indication for Atogepant for Adults With Chronic Migraine

The FDA has approved an expanded indication for atogepant (Qulipta; AbbVie) for the preventive treatment of chronic migraine in adults. The action makes atogepant the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist to gain FDA approval for the prevention of episodic and chronic migraine.

Credit: Laurin Rinder - stock.adobe.com

"Since September 2021, Qulipta has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on Qulipta to significantly reduce their migraine days," said Roopal Thakkar, senior vice president, chief medical officer, AbbVie, in a press release. "This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including Qulipta as a preventive treatment for both episodic and chronic migraine; onabotulinumtoxinA (Botox), our foundational, first FDA-approved preventive treatment for chronic migraine; and ubrogepant (Ubrelvy), an acute treatment for migraine attacks."

The expanded indication for atogepant was based on data from the pivotal phase 3 PROGRESS trial in individuals with chronic migraine, which supplements the existing data in episodic migraine. Chronic migraine is defined as headaches for 15 or more days per month, which, on at least 8 of those days per month, have the features of migraine.

The PROGRESS trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared with placebo across the 12-week treatment period in adults with chronic migraine. Additionally, the trial demonstrated that treatment with atogepant 60 mg once daily and 30 mg twice daily resulted in statistically significant improvement in all 6 secondary endpoints.

The secondary endpoints included: change from baseline in mean monthly headache days across the 12-week treatment period, with the baseline defined as the number of migraine days during the 28 days prior to the randomization date; change from the baseline in mean monthly acute medication use days across the 12-week treatment period; proportion of individuals with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period; and change from the baseline in MSQ v2.1 Role Function-Restrictive domain score at week 12.

The MSQ v2.1 is a questionnaire designed to measure health-related quality of life impairments attributed to migraines in the past 4 weeks, which are divided into 3 domains: assessing how a patient’s daily, social, and work activities are limited by migraines; how migraines prevent these activities; and assessing the emotional function related with migraine.

The overall safety profile of the PROGRESS trial was consistent with the safety findings observed in previous studies in an episodic migraine population, with the most common adverse events being constipation and nausea. Investigators included individuals with a diagnosis of chronic migraine for at least 1 year and greater than or equal to 15 headache days with greater than or equal to 8 migraine days in the 28 days prior to randomization.

Atogepant, which blocks CGRP via a once-daily dose, is available in strengths of 10 mg, 30 mg, and 60 mg for the preventive treatment of episodic migraine. Only the 60 mg dose of the drug is indicated for the preventive treatment of chronic migraine.

"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," Peter McAllister, MD, director of the New England Center for Neurology and Headache, said in a press release. "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. These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine."

Reference

U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. AbbVie. Press release. April 17, 2023. https://news.abbvie.com/news/press-releases/us-fda-approves-qulipta-atogepant-for-adults-with-chronic-migraine.htm