AbbVie Announces Positive Top-Line Results from Pivotal Phase 3 Trial of Oral CGRP Receptor Antagonist Atogepant for Chronic Migraine Prevention

AbbVie recently announced that its oral calcitonin gene-related peptide (CGRP) receptor antagonist atogepant met the primary endpoint in a pivotal Phase 3 clinical trial for the preventive treatment of chronic migraine in adults. During the 12-week treatment period, patients in the 60 mg once daily (QD) and 30 mg twice daily (BID) dose groups experienced a statistically significant reduction in the average number of migraine days per month compared to baseline versus placebo. These two doses of atogepant also achieved all secondary endpoints of the trial.

Migraine is a complex chronic disease with a high incidence rate, affecting more than 1 billion people worldwide. It is one of the leading causes of disability in people under 50 years old globally. Due to the unpredictability and variability in frequency and severity, migraine substantially impacts many aspects of an individual's life during and between attacks. Chronic migraine is a debilitating neurological condition where patients experience headaches on 15 or more days per month, lasting for more than three months, with at least 8 migraine days per month.

Atogepant is an orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine. CGRP and its receptors are expressed in areas of the nervous system associated with the pathophysiology of migraine. Studies have shown that CGRP levels increase during migraine attacks, and selective CGRP receptor antagonists can provide clinical benefits to patients with migraine. It received approval from the U.S. FDA in 2021 for the preventive treatment of episodic migraine.

▲Atogepant Molecular Structure (Image Source: PubChem)

This randomized, double-blind, placebo-controlled Phase 3 clinical trial enrolled 778 patients with at least a one-year history of chronic migraine. The trial results showed that, based on the modified intent-to-treat (mITT) patient population data over a 12-week period, patients receiving atogepant at doses of 60 mg QD or 30 mg BID experienced reductions in monthly migraine days by 6.88 and 7.46 days, respectively, compared to a reduction of 5.05 days in the placebo group.

Additionally, a key secondary endpoint measured the proportion of patients who experienced at least a 50% reduction in the average number of migraine days per month during the 12-week treatment period. Based on the mITT population, the trial demonstrated that 41.0% and 42.7% of patients in the 60 mg QD and 30 mg BID atogepant groups, respectively, achieved this threshold, compared to 26.0% in the placebo group.

"AbbVie has nearly 12 years of experience in treating chronic migraine, a debilitating condition. We understand that no two migraine patients are the same, so it is important for healthcare providers to have multiple treatment options," said Dr. Michael Severino, Vice Chairman and President of AbbVie. "We look forward to potentially expanding the patient population eligible for atogepant to include preventive treatment of chronic migraine in adults, and we will work with global regulatory authorities to submit regulatory applications."

References:

[1] AbbVie Announces Positive Phase 3 Atogepant (QULIPTA™) Data for the Preventive Treatment of Chronic Migraine. Retrieved March 11, 2022, from https://news.abbvie.com/news/press-releases/abbvie-announces-positive-phase-3-atogepant-qulipta-data-for-preventive-treatment-chronic-migraine.htm

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