AbbVie announced that Health Canada has approved QULIPTA (atogepant) for the prevention of migraine in adults who have at least four migraine days per month. QULIPTA is the first and only oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved to prevent both episodic and chronic migraine. QULIPTA's expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction of -6.9 from baseline in mean monthly migraine days compared to placebo of -5.1 across the 12-week treatment period.

The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19.2. QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine ? 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine.

The overall safety profile of QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including nausea, constipation, diarrhoea, and fatigue.