FDA Expands Approval of QULIPTA® for Chronic Migraine Treatment

Overview of QULIPTA®

The U.S. Food and Drug Administration (FDA) has extended the approval of QULIPTA® (atogepant) for the preventive treatment of chronic migraine. AbbVie, the manufacturer, announced this development through a press release. Chief Medical Officer Roopal Thakkar stated, “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.”

Mechanism of Action

Atogepant is distinguished as the first and only orally administered medication that targets a critical pathway associated with migraine pain. Unlike most drugs that inhibit the Calcitonin Gene-Related Peptide (CGRP) receptor, which are monoclonal antibodies requiring injections or intravenous infusions, atogepant functions as a small molecule antagonist that can be taken in pill form. Dr. Peter McAllister, Director of the New England Center for Neurology and Headache, remarked, “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.”

Understanding Chronic Migraine

Diagnosis and Impact

Chronic migraine is identified when a patient experiences 15 headache days each month, with at least 8 of those days qualifying as migraines. This condition can be severely debilitating, manifesting through symptoms such as intense headaches, nausea, and sensitivity to light, which significantly affect quality of life.

Existing Preventative Treatments

CGRP antagonists have emerged as effective options for preventing both episodic and chronic migraines. Dr. Werner Becker, Professor Emeritus of Clinical Neuroscience and Medicine at the University of Calgary, noted the effectiveness of CGRP antagonists, stating that while not all patients achieve complete relief, many experience substantial reductions in headache frequency. Injectable monoclonal antibodies are beneficial, but an oral alternative like atogepant offers a convenient solution for those uncomfortable with injections or unable to attend regular treatment sessions.

Clinical Evidence and Efficacy

Clinical Trial Results

The PROGRESS clinical trial, published in The Lancet, revealed that participants taking a 60 mg dose of atogepant saw a significant reduction in the average number of migraine days per month. Additionally, 40% of participants reported a 50% decrease in their migraine frequency over three months, which Dr. Becker stated is comparable to current antibody treatments. Common side effects include nausea, constipation, and sleepiness, though these are generally well tolerated.

Future Outlook

Dr. Becker expressed cautious optimism regarding the future of migraine therapies, highlighting that atogepant is currently available for episodic migraines in Canada, with hopes for chronic migraine approval to follow. He emphasized the advantage of CGRP-targeting medications, such as atogepant, noting their reduced side effects compared to older oral preventative drugs. This FDA approval enhances the treatment options for the approximately 2% of the global population suffering from chronic migraines. As Dr. Becker stated, “Having one more option is going to help a significant number of people and make things a little better for migraine sufferers as a whole.”

References

1. Newswire MP. U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. MultiVu. Accessed August 13, 2023. https://www.multivu.com/players/English/9120951-abbvie-qulipta-migraine/
2. Pozo-Rosich P, Ailani J, Ashina M, et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. Published online July 26, 2023. http://doi:10.1016/S0140-6736(23)01049-8
3. Migraine. National Institute of Health, National Institute of Neurological Disorders and Stroke. Accessed September 2023.