The Food and Drug Administration has approved Qulipta (atogepant), the first orally administered calcitonin gene-related peptide receptor antagonist, for the preventive treatment of episodic migraine in adults.
The approval 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).
Results from ADVANCE showed statistically significantly greater decreases in mean monthly migraine days 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; 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 key 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.
Additionally, a phase 2b/3 trial (ClinicalTrials.gov Identifier: NCT02848326) demonstrated that treatment with atogepant across all doses and dosing regimens resulted in significantly greater reductions in mean monthly migraine days vs placebo.
“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” said Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at University of California, Los Angeles, and King’s College, London, and co-author of the ADVANCE study. “I’m particularly encouraged by the convenience of the oral daily use of Qulipta, its rapid onset of significant efficacy, and its safety and tolerability as well as its high patient response rates.”
Nausea, constipation, and fatigue were reported to be the most common adverse reactions associated with treatment.
Qulipta is supplied as 10mg, 30mg, and 60mg tablets in 30-count bottles and is expected to be available in early October 2021.
- FDA approves Qulipta™ (atogepant), the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine. News release. AbbVie. September 28, 2021. Accessed September 29, 2021. https://apnews.com/hub/prescription-drugs.
- Qulipta. Package insert. AbbVie; 2021. Accessed September 29, 2021. https://www.rxabbvie.com/pdf/qulipta_pi.pdf.