AbbVie (NYSE:ABBV) has submitted a supplemental New Drug Application (sNDA) to the FDA to support the use of atogepant (Qulipta) as a preventive treatment of both episodic and chronic migraine.
FDA approved the drug in September 2021 as a preventive treatment of episodic migraine in adults.
In March 2022, AbbVie announced that the Phase 3 PROGRESS study testing atogepant met its primary endpoint of reducing mean monthly migraine days over placebo in patients with chronic migraine.
In its recent sNDA filing, AbbVie included data from the pivotal Phase 3 PROGRESS trial in patients with chronic migraine. The placebo-controlled study met its primary endpoint, which related to a statistically significant reduction from baseline in mean migraine days per month.
Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) developed as a preventive migraine therapy.