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AbbVie reveals results from pivotal atogepant trial



Study has been focusing on atogepant for the prevention of episodic migraine attacks

AbbVie has announced positive data from its pivotal phase 3 ELEVATE study, studying its atogepant therapy.

Also known as Qulipta, the drug has been developed for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral medications.

The ELEVATE trial met all primary and secondary endpoints. The primary endpoint was the change from baseline in mean monthly migraine days (MMDs) across 12 weeks, while the secondary targets included achieving a more than 50% reduction in MMDs.

The data from the study showed adult patients in the 60mg once daily arm established a decrease of 4.20 days in their mean monthly migraine days across the treatment period. This period is significantly greater than the 1.85-day reduction observed within the placebo arm.

A total of 309 patients were recruited for the study and of these participants, 56% had previously failed two classes of oral migraine preventive medications and 44% had previously failed three or more classes.

Professor Patricia Pozo-Rosich, head of neurology section, Vall d’Hebron Hospital and Institute of Research, explained: “For those living with migraine, the path towards effective treatment can be a long and complex journey. The ELEVATE trial demonstrates atogepant as a once-daily oral treatment that can significantly reduce monthly migraine days across a lifelong disorder, allowing people to experience relief in their daily lives.”

Dawn Carlson, vice president, neuroscience development at AbbVie, reflected: “We understand that people living with migraine endure a chronic neurological disease and we are dedicated to providing them the best chance to live a life with less frequent migraines.”

She added: “The data presented at the American Academy of Neurology (AAN) underscores the important role of atogepant, not only as a treatment option for people living with episodic migraine but also for those whose previous treatments failed to help reduce the impact of migraine on their lives.”

Migraine impacts the lives of one billion people worldwide and is one of the highest causes of disability for people below the age of 50. Those with migraine experience frequent disabling attacks, preventing them from performing daily activities and profoundly affecting their quality of life.

The debilitating condition imposes both a social and economic burden, causing a significant burden for people living with migraine.

The data will be presented during the AAN Annual Meeting next week.

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