AbbVie Announces Atogepant Meets Primary Endpoint in Phase 3 ADVANCE Trial for Migraine Prevention

Today, AbbVie announced that its investigational oral CGRP receptor antagonist, atogepant, met the primary endpoint in the Phase 3 ADVANCE clinical trial for the prevention of migraine. During the 12-week treatment period, all doses significantly reduced the mean number of monthly migraine days compared with placebo. Based on these Phase 3 results and previously positive Phase 2/3 clinical trial data, AbbVie plans to pursue regulatory submissions in the United States and other countries. Full data results will be presented at upcoming medical conferences and/or published in peer-reviewed journals.

Migraine is a complex chronic disease characterized by headaches along with neurological and autonomic symptoms. It has a high prevalence, affecting over 1 billion people globally, and is the leading cause of disability among individuals under the age of 50 worldwide. Due to the unpredictability and fluctuation in the frequency and severity of attacks, migraine substantially impacts many aspects of an individual's life during both the ictal and interictal phases. Daily activities, work, school, and personal relationships are adversely affected, imposing a significant burden on patients with migraine, as well as their families and friends.

Atogepant is an orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with the pathophysiology of migraine. Studies have shown that CGRP levels are elevated during migraine attacks, and selective CGRP receptor antagonists provide clinical benefits to patients with migraine.

▲ Molecular structure of atogepant (Image source: PubChem)

In the ADVANCE trial, a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 clinical study, 910 patients experiencing 4 to 14 migraine days per month were randomly assigned to one of four treatment groups receiving atogepant (10 mg, 30 mg, or 60 mg) or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population, which comprised 873 patients.

Trial results demonstrated that all atogepant dose groups met the primary endpoint. The mean reduction in monthly migraine days was 3.69, 3.86, and 4.2 days in the 10 mg, 30 mg, and 60 mg atogepant groups, respectively, which was significantly greater than the 2.48-day reduction observed in the placebo group (p<0.0001).

The trial also met its key secondary endpoint. During the 12-week study period, the proportions of patients achieving a ≥50% reduction in mean monthly migraine days were 55.6%, 58.7%, and 60.8%, respectively, compared with 29.0% in the placebo group (p<0.0001).

“Although migraine attacks can be debilitating, they are a treatable condition,” said Dr. Thomas J. Hudson, Senior Vice President of Research and Development and Chief Scientific Officer at AbbVie Inc. “Our goal is to provide patients and healthcare providers with a simple, once-daily oral treatment.”

References:

[1] AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention. Retrieved July 29, 2020, from https://www.prnewswire.com/news-releases/abbvie-announces-positive-phase-3-data-for-atogepant-in-migraine-prevention-301101791.html

Original Label Express | Over Half of Migraine Patients Experienced a 50% Reduction in Attack Frequency, AbbVie’s Oral CGRP Receptor Antagonist Met Phase 3 Clinical Endpoints

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