FDA Expands Approval of QULIPTA® for Chronic Migraine Treatment

Overview of QULIPTA®

The U.S. Food and Drug Administration (FDA) has granted expanded approval for QULIPTA® (atogepant) to be used in the preventative treatment of chronic migraine. According to a press release from AbbVie, the drug’s manufacturer, 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.”

Unique Mechanism of Action

Atogepant is distinguished as the first and only orally administered drug that targets a critical pathway involved in migraine pain. Most medications that block the Calcitonin Gene-Related Peptide (CGRP) receptor are monoclonal antibodies, which require injection or intravenous infusion. In contrast, atogepant is 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 Symptoms

Chronic migraine is characterized by the frequency of attacks, with a diagnosis made when a patient experiences 15 headache days per month, at least 8 of which meet migraine criteria. This condition can be debilitating, often accompanied by severe headaches, nausea, and sensitivity to light, significantly impacting the quality of life for many patients.

Existing Preventative Treatments

CGRP antagonists have proven effective for preventing both episodic and chronic migraines. Dr. Werner Becker, Professor Emeritus of Clinical Neuroscience and Medicine at the University of Calgary, highlighted the benefits of these treatments: “There are patients who do get a 100% response. They are the lucky ones. Even if a smaller number get a 75% response, you still have around 50% of people who have their headache frequency cut in half.”

While injectable monoclonal antibodies are effective for many, an oral alternative like atogepant offers a convenient option for patients who may fear needles, cannot perform injections, or cannot attend regular medical appointments. Additionally, atogepant has a shorter elimination time from the body, clearing within days compared to the months required for antibodies. This is particularly advantageous for women considering pregnancy, as they can discontinue treatment and eliminate CGRP blockers swiftly.

Efficacy of Atogepant

Clinical Trial Results

The PROGRESS clinical trial, published in The Lancet, demonstrated that participants receiving a 60 mg dose of atogepant saw a significant reduction in the average number of migraine days per month. Notably, 40% of participants experienced a 50% reduction in their three-month average of migraine days. Professor Becker noted that these results are comparable to existing antibody treatments.

Side Effects and Tolerability

Common side effects of atogepant, which are generally well tolerated, include nausea, constipation, and sleepiness.

Future Perspectives on Migraine Therapy

Potential for Broader Accessibility

Dr. Becker expressed cautious optimism about the future of migraine therapies, stating, “[Atogepant is] available for episodic migraines in Canada and we hope that the chronic approval will follow.” He emphasized that CGRP-targeting medications like atogepant tend to have fewer side effects than older oral preventative medications.

For the approximately 2% of the global population experiencing chronic migraines, this FDA approval broadens the range of available treatment options. As Dr. Becker concluded, “We really can’t predict who’ll respond to one drug or another, so 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.
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.
3. Migraine. National Institute of Health, National Institute of Neurological Disorders and Stroke. Accessed September 2023.