Qulipta Approval Expanded to Include Preventive Treatment of Chronic Migraine

The Food and Drug Administration (FDA) has expanded the approval of Qulipta^® (atogepant) to include the preventive treatment of chronic migraine in adults. Previously, the oral calcitonin gene-related peptide (CGRP) receptor antagonist was only approved to prevent episodic migraine.

The approval was supported by data from the randomized, double-blind, placebo-controlled phase 3 PROGRESS study (ClinicalTrials.gov Identifier: NCT03855137), which included adults with at least a 1-year history of chronic migraine. The mean migraine frequency for study participants at baseline was approximately 19 migraine days per month.

Patients were randomly assigned to receive atogepant 60mg once daily (n=262) or placebo (n=259) for 12 weeks. A total of 463 (89%) of these patients completed the 12-week double-blind study period.

Results showed that patients in the atogepant 60mg daily treatment arm experienced a statistically significant reduction from baseline in mean monthly migraine days (primary endpoint) of 6.9 days compared with 5.1 days in the placebo arm (P <.001).

Improvements in key secondary endpoints were also observed with atogepant 60mg daily vs placebo, respectively:

• Mean change from baseline in mean monthly headache days: -7.0 vs -5.1 (P <.001);
• Mean change from baseline in mean monthly acute medication use days: -6.1 vs -4.1 (P <.001);
• Proportion of patients achieving at least a 50% reduction from baseline in mean monthly migraine days: 41% vs 26% (P <.001);
• Mean change from baseline in Migraine Specific Quality of Life Questionnaire (MSQ) version 2.1 Role Function-Restrictive domain score: 23.2 vs 17.2 (P <.001);
• Mean change from baseline in Activity Impairment in Migraine-Diary Performance of Daily Activities (AIM-D PDA) domain score: -12.8 vs -9.4 (P <.001);
• Mean change from baseline in Activity Impairment in Migraine-Diary Physical Impairment (AIM-D PI) domain score: -10.6 vs -7.9 (P =.003).

The safety profile of atogepant was found to be consistent with that seen in previous studies in patients with episodic migraine. The most common adverse events reported were constipation, nausea, and fatigue/sleepiness.

Qulipta is available as 10mg, 30mg, and 60mg tablets in 30-count bottles; only the 60mg dose is indicated for the preventive treatment of chronic migraine.