CGRP Medication Atogepant Gains European Commission Approval as Migraine Preventive

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In 2 pivotal phase 3 trials, atogepant met its primary end point of superior reduction in monthly migraine days vs placebo, with consistent safety throughout.

Roopal Thakkar, MD, senior vice president, Development and Regulatory Affairs, and chief medical officer, AbbVie

Roopal Thakkar, MD

The European Commission recently approved AbbVie’s atogepant (Aquipta) for the prophylaxis of migraine in adults who have 4 or more migraine days per month, becoming the first and only calcitonin gene-related peptide (CGRP) agent indicated for prevention of both episodic and chronic migraine.1

"The European Commission approval of AQUIPTA is a significant milestone for people suffering from four or more migraine days per month as it provides a once-daily treatment option that can reduce the number of migraine days and the associated pain they experience,” Roopal Thakkar, senior vice president, Development and Regulatory Affairs, and chief medical officer, AbbVie, said in a statement.1 "With this approval, AbbVie can help meet additional migraine patient needs through our enhanced portfolio of treatment options across migraine frequencies, including episodic and chronic migraine."

The approval was based on data from 2 phase 3 studies, PROGRESS (NCT03855137) and ADVANCE (NCT02848326), in which atogepant-treated patients showed greater reduction of monthly migraine days (MMDs) than placebo. Atogepant originally received FDA approval as a preventive for episodic migraine in September 2021, and had its label expanded to include chronic migraine earlier this year.2 It remains approved in the US for both chronic and episodic migraine and in Canada for episodic migraine under the brand name Qulipta.

Both studies met their primary end point of a statistically significant reduction in mean MMDs relative to placebo over a 12-week treatment period. Each study differed, as PROGRESS included 778 patients with chronic migraine experiencing at least 15 headache days per month for more than 3 months and ADVANCE included 873 patients with episodic migraine who had at least 4 headache days per month. Patients in PROGRESS were randomized to receive 60-mg QD of atogepant, 30-mg BID of atogepant, or placebo, while those in ADVANCE were randomly assigned 1:1:1:1 to receive once-daily dose of oral atogepant at doses of 10 mg, 30 mg, or 60 mg, or placebo.

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Across the 12 weeks of treatment, those in the 60-mg QD and 30-mg BID arms of PROGRESS 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). In ADVANCE, those in the atogepant 10-, 30-, and 60-mg dose groups experienced decreases in mean monthly headache days of 3.9, 4.0, and 4.2 days, respectively, vs a 2.5 day decline in the placebo arm (P <.0001 for all doses).

Additional findings from a prespecified exploratory analysis of ADVANCE showed that atogepant groups visually separated from placebo in a graphical representation of the mean change in number of migraine days for each 4-week interval during the treatment period; however, no definite conclusions could be drawn from this data. Differences from placebo were observed within the first 4 weeks after the initiation of treatment and were maintained during each subsequent 4-week interval.3

"Migraine is a neurological disease that causes recurrent pain and other migraine-associated symptoms, with attacks that can last several hours to days, leading to missed life opportunities," Patricia Pozo-Rosich, MD, PhD, head of Neurology Section, Vall d’Hebron Hospital and Institute of Research, Spain, said in a statement.1 "The pivotal Phase 3 studies demonstrated AQUIPTA provides significant and sustained reduction of mean monthly migraine days. This allows people to experience relief with a simple to take once-daily tablet, including those who have had an insufficient response to prior preventative migraine treatments."

Recently, at the 2023 American Headache Society (AHS) Annual Meeting, data from a matching-adjusted indirect comparison analysis showed greater improvements in both efficacy and quality of life among patients treated with 60 mg QD of atogepant than those on Rimegepant (Nurtec ODT; Biohaven) 75 mg every other day. In total, the analysis included 252 patients in the pooled atoegpent 60 mg QD group and 348 patients in the rimegepant 75 mg QOD group, with baseline characteristics that were balanced after weighting. Across weeks 1-12, atogepant-treated patients demonstrated a statistically significant greater reduction in mean MMDs vs rimegepant (mean difference, ­­–1.65; 95% CI, –2.49 to –0.81; <.001).

REFERENCES
1. AbbVie announces European Commission approval of Aquipta (atogepant) for the preventive treatment of migraine in adults. News release. AbbVie. August 17, 2023. Accessed August 18, 2023. https://news.abbvie.com/news/press-releases/news-type/rd-news/abbvie-announces-european-commission-approval-aquipta-atogepant-for-preventive-treatment-migraine-in-adults.htm
2. U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. News release. AbbVie. April 17, 2023. Accessed August 18, 2023. https://news.abbvie.com/article_display.cfm?article_id=12576
3. Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. NEJM. 2021; 385:695-706. doi:10.1056/NEJMoa2035908
4. Tassorelli C, Onishchenko K, Duan M, et al. Comparative efficacy, quality of life, and safety/tolerability of atogepant and rimegepant in migraine prevention: a matching-adjusted indirect comparison. Presented at: 2023 AHS Annual Meeting; June 15-18; Austin, TX. P-42.
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