AbbVie Submits sNDA to FDA for Qulipta for Preventive Treatment of Chronic Migraine

Submission is based on phase 2 study results evaluating atogepant in adults who met the primary endpoint of a statistically significant reduction from the baseline compared with a placebo.

AbbVie has submitted a supplemental new drug application (sNDA) to the FDA for atogepant (Qulipta) to support the preventive treatment of chronic migraine in adults.

If approved, atogepant would be the first gepant, an oral calcitonin gene-related peptide receptor antagonist, approved for the broad indication of the preventive treatment of both chronic and episodic migraines.

The sNDA submission includes 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, according to investigators.

“Having 1 oral medication to treat both episodic and chronic migraine would be an important advancement for health care providers and patients,” Michael Gold, MD, therapeutic area head of neuroscience development at AbbVie, said in a statement.

“This sNDA approval would also diversify AbbVie’s migraine portfolio and make it the only company to offer 2 approved preventive treatments for those living with chronic migraine,” he said. “No 2 migraine patients are alike, so having multiple treatment options with unique mechanisms of action is critical.”

The PROGRESS trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared with the 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 prevents these activities; and assessing the emotional function related with migraine.

The overall safety profile of the study 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 is FDA-approved to treat individuals with episodic migraines. The drug has not been approved in the United States for the preventive treatment of chronic migraine, and its efficacy and safety have not been evaluated by regulatory authorities.

Reference

AbbVie submits supplemental new drug application to US FDA for atogepant (Qulipta) to support label expansion for the preventive treatment of migraine. AbbVie. News release. June 21, 2022. Accessed June 22, 2022. https://news.abbvie.com/news/press-releases/abbvie-submits-supplemental-new-drug-application-to-us-fda-for-atogepant-qulipta-to-support-label-expansion-for-preventive-treatment-migraine.htm