General Information

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

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

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

Mechanism of Action

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

Side Effects

Adverse effects associate with the use of Qulipta may include, but are not limited to, the following:

• nausea
• constipation
• fatigue

Clinical Trial Results

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.