The decision to approve AbbVie’s drug was made based on data from a clinical program evaluating the efficacy, safety and tolerability of atogepant in nearly 2,000 patients with episodic migraine, defined as 4 to 14 migraine days per month. One of the studies, the pivotal phase 3 ADVANCE study, included 873 patients with episodic migraine who were randomized 1: 1: 1: 1 to receive a once daily dose of oral atogepant (10 mg, 30 mg or 60 mg) or placebo for 12 weeks.2
“Millions of migraine sufferers often lose productive days each month because the attacks can be debilitating. Qulipta can help by reducing monthly migraine days with a once-daily oral dose that works quickly and continuously,” Michael Severino, MD, vice president and chairman, AbbVie, said in a press release.1 “We are proud that AbbVie is now the only pharmaceutical company to offer three products covering the full spectrum of migraine treatment, which include preventative therapies for chronic and episodic migraine and acute treatment for migraine attacks. “
Atogepant has demonstrated the ability to improve several predefined and multiplicity controlled secondary endpoints during the 12 week period of the ADVANCE study. Patients in the 10, 30 and 60 mg of atogepant groups had a decrease in the mean number of headache days per month of 3.9 (baseline, 8.4), 4.0 (baseline, 8.8 ) and 4.2 (baseline, 9.0) days versus 2.5 days. -day (baseline, 8.4) decline in the placebo arm (P 2 These resulted in 56%, 59% and 61% of patients in the 10 mg, 30 mg and 60 mg dose groups, respectively, compared to 29% of patients in the placebo arm.
Read more: Migraine and psychiatric comorbidity
Additional results showed that treatment with the drug met the primary endpoint, with decreases in the mean number of monthly headache days of 3.7, 3.9 and 4.2 days, respectively, in the 10 mg (n = 214), 30 mg (n = 223) and 60 mg (n = 222) groups of atogepant compared to a 2.5 day drop in the placebo arm.3
The study also found a change of -3.7, -3.7, and -3.9 in the average number of days of medication use to treat migraine attacks per month from baseline which was reported in all 3 treatment groups, compared to -2.4 for placebo (P <.001 for all placebo comparisons a or more reduction in the mean migraine days was reported by of participants mg togepant group those group. atogepant and with>2
For the 30 mg and 60 mg dose groups, the researchers observed significantly greater score improvements of -2.5 points (P = 0.0005) and -3.3 points (P
“This approval reflects a broader shift in the treatment and management paradigm for the migraine community. 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 ”, Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California at Los Angeles and King’s College London, and co-author of the ADVANCE study, said in a statement.1 “I am particularly encouraged by the convenience of daily oral use of QULIPTA, its rapid onset of significant efficacy, its safety and tolerability, and its high patient response rates. This is an important step in the preventative treatment of migraine which will hopefully help many patients for years to come.
(A version of this article originally appeared with Psychiatry Times’ sister post Neurology Live-Ed.)
1. The FDA approves QULIPTA ™ (atogepant), the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine. Press release. AbbVie. September 28, 2021. Accessed September 28, 2021. https://news.abbvie.com/news/press-releases/fda-approves-qulipta-atogepant-first-and-only-oral-cgrp-receptor-antagonist-specifically-development-for-preventive-treatment-migraine. htm? view_id = 1531
2. Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. NEJM. 2021; 385: 695-706.
3. AbbVie reports positive Phase 3 data for Atogepant in the prevention of migraine. Press release. AbbVie. July 29, 2020. Accessed August 23, 2021. news.abbvie.com/news/press-releases/abbvie-announces-positive-phase-3-data-for-atogepant-in-migraine-prevention.htm