FDA expands Qulipta indication to include chronic migraine prevention
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Key takeaways:
- Qulipta, an oral CGRP receptor antagonist, has been approved to prevent chronic and episodic migraine in adults.
- FDA approval was based on positive results from the phase 3 PROGRESS trial.
The FDA has approved expanding the indication of Qulipta, an oral calcitonin gene-related peptide receptor antagonist, for preventing migraine in adults.
According to a press release from AbbVie, the approval makes Qulipta (atogepant, AbbVie) the only calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent both episodic and chronic migraine, defined as experiencing headaches for at least 15 days per month, with at least 8 of those days associated with migraine.
“Since September 2021, Qulipta has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine,” Roopal Thakkar, AbbVie senior vice president and chief medical officer, said in the 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.”
FDA approval was based on data from the phase 3 PROGRESS trial, which evaluated a once-daily, 60 mg dose of atogepant for adults with chronic migraine. The study met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days, the average of which was 19, compared with placebo after 12 weeks of treatment. Statistically significant improvements also were noted in all six secondary endpoints, which included a measure of the proportion of patients with 50% reduction in mean monthly migraine days as well as improvements in function and reduction in activity impairment due to migraine, the release stated.
Atogepant, which works by blocking CGRP, is currently available in 10 mg, 30 mg and 60 mg doses, but only the 60 mg dose is approved for chronic migraine preventive treatment, according to the release. The most common adverse events include constipation, nausea and fatigue or 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, said in the release.