General Information

Qulipta (atogepant) is a calcitonin gene-related peptide receptor antagonist.

Qulipta is specifically indicated for the preventive treatment of episodic and chronic migraine in adults.

Qulipta is supplied as a tablet for oral administration. The recommended dose for episodic migraine 10 mg, 30 mg, or 60 mg taken orally once daily with or without food. The recommended dose for for chronic migraine is 60 mg taken once daily.

Clinical Trial Results

Episodic Migraine

FDA approval was based on the pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial. The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All Qulipta dose groups met the primary endpoint and demonstrated statistically significant reductions in mean monthly migraine days compared to placebo. Patients treated with 60 mg of Qulipta across 12 weeks experienced a 4.2-day reduction from baseline of 7.8. A key secondary endpoint in the ADVANCE trial measured the proportion of patients that achieved a ≥50% reduction in monthly migraine days across the 12-week treatment period. The trial demonstrated that 56%/59%/61% of patients in the 10 mg/30 mg/60 mg Qulipta arms, respectively, achieved a 50-100% reduction, compared to 29% of patients in the placebo arm (all dose groups vs. placebo).

In addition a pivotal Phase 2b/3 trial demonstrated that all active treatment arms met the primary efficacy endpoint of change from baseline in mean monthly migraine days with significantly greater reductions in mean monthly migraine days across the 12-week treatment period for all three Qulipta treatment groups compared with placebo. All three Qulipta treatment groups also met the secondary efficacy endpoint of change from baseline in mean monthly headache days.

Chronic Migraine

FDA approval for the chronic migraine indication was based on the pivotal Phase 3 PROGRESS trial evaluating Qulipta 60 mg once daily in adult patients with chronic migraine. The trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period. The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19.3 Treatment with Qulipta also resulted in statistically significant improvements in all six secondary endpoints. This included key secondary endpoints that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine.