Qulipta

The approval of Qulipta was based on data from several clinical studies evaluating the efficacy, safety, and tolerability of atogepant in approximately 2500 patients with episodic migraine (4-14 migraine days per month), including the phase 3 ADVANCE trial (ClinicalTrials.gov Identifier: NCT03777059).

In the ADVANCE study, 910 patients were randomly assigned to receive Qulipta 10mg (n=222), Qulipta 30mg (n=230), Qulipta 60mg (n=235), or placebo (n=223) once daily for 12 weeks. Patients were allowed to use acute headache treatments just not medications that act on the CGRP pathway. The average age of the study participants was 42 years, 89% were female, 83% were White, 14% were Black, and 9% were Hispanic or Latino. Mean migraine frequency at baseline was ~8 migraine days/month and was similar across treatment groups. A total of 805 patients completed the 12-week double-blind study period.

Results from ADVANCE showed statistically significantly greater decreases in mean monthly migraine days (primary endpoint) with atogepant compared with placebo (3.7 days with 10mg, 3.9 days with 30mg and 4.2 days with 60mg vs 2.5 days with placebo; all P <.001). Moreover, a greater proportion of patients treated with atogepant (10mg/30mg/60mg) achieved a ≥50% reduction in mean monthly migraine days (key secondary end point) across the 12-week treatment period compared with placebo (56%/59%/61%, respectively, vs 29%; P <.001). 

The ADVANCE trial also met additional secondary endpoints including change from baseline in mean monthly headache days, mean monthly acute-medication use days, and mean monthly performance of daily activities and physical impairment domain scores of the Activity Impairment in Migraine-Diary, and change from baseline in the Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive domain score at week 12. 

Qulipta was also evaluated in a phase 2b/3 trial (ClinicalTrials.gov Identifier: NCT02848326) that included 652 patients who were randomly assigned to receive Qulipta 10mg (n=94), Qulipta 30mg (n=185), Qulipta 60mg (n=187), or placebo (n=186).  Patients were allowed to use acute headache treatments just not medications that act on the CGRP pathway. The average age of the study participants was 40 years, 87% were female, 76% were White, 20% were Black, and 15% were Hispanic or Latino. Mean migraine frequency at baseline was ~8 migraine days/month and was similar across treatment groups. A total of 541 patients completed the 12-week double-blind study period.

Findings showed a significantly greater reduction in mean monthly migraine days across the 12-week treatment period in all 3 Qulipta treatment groups, compared with placebo (4 days with Qulipta 10mg (P =.024), 3.8 days with Qulipta 30mg (P =.039) and 3.6 days with Qulipta 60mg (P =.039) vs 2.8 days with placebo.