Atogepant (QULIPTA®) Proves Successful in Preventing Episodic Migraine in Patients with Prior Treatment Failure – AbbVie Announces at AAN Annual Meeting

At the 2023 American Academy of Neurology (AAN) Annual Meeting in Boston, Massachusetts, AbbVie (NYSE: ABBV) presented the results of their successful Phase 3 ELEVATE study. Their research examined the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications, and found that adult patients in the atogepant 60 mg once daily (QD) arm experienced a statistically significant decrease of 4.20 days in their mean monthly migraine days (MMDs) compared to the 1.85 day reduction in the placebo arm (p<0.0001). These promising results demonstrate the potential of atogepant for migraine prevention.

At AAN, we proudly presented data on the power of atogepant to reduce the impacts of migraine on the lives of those living with episodic migraine, as well as those whose previous treatments had been unsuccessful. At AbbVie, we are dedicated to providing those living with migraine the best chance to lead a life with fewer migraines, understanding the struggles of this chronic neurological disease. We believe that atogepant can be an effective treatment option for those affected by migraine.

The ELEVATE study concluded with encouraging results, showing a statistically significant reduction in migraine-related days (MMDs) in those with episodic migraine who took atogepant 60 mg QD compared to placebo. Across 12 weeks, the mean MMDs decreased, as did acute medication use days, with more than 50% of participants experiencing a reduction in MMDs. These results highlight the potential of atogepant to reduce the impact of migraine on sufferers.

A total of 309 participants took part in a study to assess the efficacy and safety of atogepant, a migraine preventive medication. Of these, 56% had previously failed two classes of oral medications, while 44% had failed three or more classes. The results revealed that atogepant 60mg QD was well-tolerated and the safety results were in line with the known safety profile of the drug.

The most common reported adverse events in either treatment arm included constipation (10.3% vs 2.5%), COVID-19 (8.3% vs 9.6%), nausea (7.1% vs 3.2%), and nasopharyngitis (5.1% vs 7.6%). This study provides further evidence for the use of atogepant as an effective and safe migraine preventive medication.

The journey to finding effective treatment for migraine can be a long and challenging one, but the ELEVATE trial has found that atogepant, a once-daily oral medication, can help to reduce the number of monthly migraine days for those living with the lifelong disorder. This breakthrough can bring relief to those who have been failed by other preventive migraine treatments, allowing them to enjoy a greater quality of life.

Professor Patricia Pozo-Rosich, MD, PhD, Head of Neurology Section at Vall d’Hebron Hospital and Institute of Research in Spain, remarks: “This is an incredible advancement for those living with migraine.”

Migraine is a widespread and disabling disease that affects billions of people globally, robbing them of their quality of life and causing a significant economic burden to healthcare systems. It is one of the leading causes of disability among people under 50 years of age, with frequent and debilitating migraine attacks preventing them from performing even the simplest of daily activities. Sufferers of migraine are all too familiar with the social and financial burdens that come with this disease, making it an issue that needs to be addressed.

The U.S. Food and Drug Administration recently gave the green light to QULIPTA®, the first-ever oral calcitonin gene-related peptide (CGRP) receptor antagonist proven to prevent both episodic and chronic migraine in adults. With this approval, AbbVie is now working on international regulatory submissions for atogepant to make it available for migraine sufferers around the world.

About the ELEVATE Study

The ELEVATE study was an exciting global trial involving adults with episodic migraine who had previously failed two to four classes of oral prophylactic treatments. The study randomly assigned participants to receive either atogepant 60 mg once daily or placebo, and sought to determine the safety, tolerability, and efficacy of atogepant.

The primary endpoint was the reduction of mean monthly migraine days throughout the 12-week duration of the study, and secondary endpoints included the achievement of more than 50% reduction in MMDs, as well as changes in MMDs and acute medication use days from baseline.

About Atogepant (QULIPTA®)

Atogepant is an exciting new preventive treatment for migraine in adults, developed to specifically target CGRP receptors, which are known to be involved in migraine pathophysiology. Studies suggest that blocking these receptors with atogepant can offer clinical benefit in migraine, as CGRP levels are known to be elevated during migraine attacks.

Unfortunately, atogepant is not yet approved in the UK or EU, so its safety and efficacy still need to be evaluated. Nonetheless, it is a promising new treatment and could potentially offer much-needed relief for migraine sufferers.

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