FDA Expands Atogepant Approval to Include Chronic Migraine

Megan Brooks

April 28, 2023

The US Food and Drug Administration (FDA) has approved an expanded indication for atogepant (Qulipta, Abbvie) to include prevention of chronic migraine in adults.

The approval makes atogepant the first, and only, oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic, the company said in a news release.

As previously reported by Medscape Medical News, the FDA initially approved atogepant in 2021 for prevention of episodic migraine in adults.

Once-daily atogepant is available in three doses — 10 mg, 30 mg, and 60 mg — for prevention of episodic migraine. However, only the 60 mg dose of medication is indicated for the preventive treatment of chronic migraine.

The expanded indication in chronic migraine is based on positive results of the phase 3 PROGRESS trial evaluating atogepant in more than 700 adults with chronic migraine.

The trial met the primary endpoint of statistically significant reduction from baseline in mean monthly migraine days with atogepant compared with placebo across the 12-week treatment period.

Treatment with atogepant also led to statistically significant improvements in all six secondary endpoints, including the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across 12 weeks and improvements in function and reduction in activity impairment due to migraine.

As reported by Medscape Medical News, the efficacy results are consistent with those in the ADVANCE episodic migraine trial.  

The overall safety profile of atogepant is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea, and fatigue/sleepiness.

"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, Stamford, Connecticut, said in the release.

The data demonstrate that atogepant "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," McAllister added.

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