New Relief for Migraine Sufferers as FDA Approves AbbVie's Atogepant

AbbVie_© AbbVie Inc. All rights reserved.

© AbbVie Inc. All rights reserved.

The U.S. Food and Drug Administration (FDA) greenlit AbbVie’s migraine treatment Qulipta (atogepant) as a preventative treatment for episodic migraine headaches. Qulipta is the first calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for this indication.

Qulipta is a once-daily oral medication, which marks a shift in the treatment of migraine-associated issues. Data from the Phase III ADVANCE study showed that patients who received Qulipta experienced a 50% to 100% reduction in monthly migraine days across 12 weeks. 

Data from the ADVANCE study showed that atogepant met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days. Secondary endpoints met in the study showed that atogepant achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. At the time of the study, AbbVie said a majority of patients in each dosing group hit this goal during the trial.

Qulipta will bolster AbbVie’s migraine product line that includes the crown jewel of Botox, as well as Ubrelvy (ubrogepant), which was approved by the FDA for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. 

Migraine is a complicated neurological disorder marked by episodic headache and other associated indications, such as vomiting, nausea, phonophobia, which is a fear of loud noises, and/or photophobia, light sensitivity. 

An estimated 12% to 14% of all people, more than a billion worldwide, are hit by a migraine headache. In the United States, about 29 million people are affected. It is the highest cause of disability worldwide for people under 50 years of age.

AbbVie President Michael Severino stated that Qulipta could help the millions of people who suffer from migraines through daily dosing. A reduction in the number of migraine days means that many people who experience the debilitating effects will regain days that are often lost. 

“We are proud that AbbVie is now the only pharmaceutical company to offer three products across the full spectrum of migraine treatment, which includes preventive therapies for chronic and episodic migraine and an acute treatment for migraine attacks,” Severino said in a statement.

Peter J. Goadsby, a professor at the University of California, Los Angeles, and King's College London, who co-authored the ADVANCE study, called the FDA approval of Qulipta a milestone in the treatment of migraine. Goadsby, who won the prestigious Brain Prize in 2021 for his research into CGRP’s role in migraine attacks, touted the rapid onset of the drug’s efficacy and the high patient response rate. 

“This is a milestone in preventive migraine treatment that I hope will help many patients for years to come,” Goadsby shared in a statement. 

Qulipta is expected to be available for patients in October. 

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