The U.S. Food and Drug Administration (FDA) has approved expanding the indication of AbbVie’s QULIPTA (atogepant) for the preventive treatment of migraine in adults. The approval makes QULIPTA the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. People living with chronic migraine experience headaches for 15 or more days per month, with at least eight of those days associated with migraine [1].

QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine. The overall safety profile of QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea and fatigue/sleepiness.

QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine. The overall safety profile of QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea and fatigue/sleepiness.

“Since September 2021, QULIPTA has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on QULIPTA to significantly reduce their migraine days,” said Roopal Thakkar, senior vice president, chief medical officer, AbbVie. “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.”

QULIPTA’s expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period [2]. The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19 [3]. The trial also demonstrated that treatment with QULIPTA resulted in statistically significant improvements in all six secondary endpoints [3]. This includes key secondary endpoints that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine [4]. These efficacy results are consistent with those in the ADVANCE episodic migraine trial [5].

“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,” said Peter McAllister, M.D., Director of the New England Center for Neurology and Headache. “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.”

References:
1. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
2. AbbVie. Data on File: ABVRRTI73750
3. Efficacy, Safety, and Tolerability, of Atogepant for the Prevention of Chronic Migraine. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03855137?term=NCT03855137& draw=2&rank=1. Accessed on March 15, 2023.
4. AbbVie. Data on File: ABVRRTI73750
5. 2-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03777059.

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