AbbVie’s oral calcitonin gene-related peptide receptor antagonist, marketed as Qulipta, is now approved for both chronic and episodic migraine. The FDA's decision was supported by data from the PROGRESS trial.
The FDA has expanded the indication for atogepant (Qulipta; AbbVie) to include the prevention of chronic migraine in adults, adding to its existing indication for episodic migraine, according to an announcement from AbbVie.1 The approval was granted based on data from the phase 3 PROGRESS trial (NCT03855137) that showed that 60-mg atogepant resulted in a significant reduction in mean monthly migraine days (MMDs) compared with placebo across 12 weeks of treatment.
The oral calcitonin gene-related peptide (CGRP) receptor antagonist was originally approved in September 2021,2 based on the results of its full clinical development program, including the ADVANCE study (NCT02848326). The treatment was submitted for this supplemental approval in June 2022,3 just a few months after AbbVie announced it had met the primary end point in PROGRESS.4
PROGRESS was a double-blind, placebo-controlled, parallel-group study that included 778 patients with chronic migraine experiencing at least 15 headache days per month for more than 3 months (modified intent-to-treat, n = 755). Each patient was randomized to receive 60-mg QD of atogepant, 30-mg BID of atogepant, or placebo, for the 12-week treatment period. Across the 12 weeks of treatment, those in the 60-mg QD and 30-mg BID arms experienced decreases of 6.88 MMDs and 7.46 MMDs, respectively, compared with patients in the placebo arm, who had a decrease of 5.05 MMDs (60 mg QD vs placebo, P = .0009; 30 mg BID vs placebo, P <.0001).
"The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe and effective treatment option in a convenient, once-daily pill," Peter McAllister, MD, director of the New England Center for Neurology and Headache, said in a statement.1 "Qulipta's data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks. These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine."
Atogepant is available in 3 doses for the preventive treatment of episodic migraine: 10 mg, 30 mg, and 60 mg; however, only the 60-mg dose is indicated for the preventive treatment of chronic migraine. The overall safety profile of the therapy has been consistent with the episodic migraine patient population. The most common adverse events including constipation, nausea and fatigue/sleepiness.5,6
“Now, those with the most challenging to treat chronic migraine can also rely on Qulipta to significantly reduce their migraine days," said Roopal Thakkar, the senior vice president and chief medical officer at AbbVie, said in a statement.1 "This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including Qulipta as a preventive treatment for both episodic and chronic migraine; Botox (onabotulinumtoxinA), our foundational, first FDA-approved preventive treatment for chronic migraine; and Ubrelvy (ubrogepant), an acute treatment for migraine attacks."
ADVANCE 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.5 Atogepant demonstrated an ability to improve several prespecified, multiplicity-controlled secondary end points across the 12-week period. Those in the atogepant 10-, 30-, and 60-mg dose groups experienced decreases in mean monthly headache days of 3.9 (baseline, 8.4), 4.0 (baseline, 8.8), and 4.2 (baseline, 9.0) days vs a 2.5-day (baseline, 8.4) decline in the placebo arm (P <.0001 for all doses).2 These translated to 56%, 59%, and 61% of patients in the 10-mg, 30-mg, 60-mg dose groups, respectively, compared with 29% of patients in the placebo arm.