FDA Approves AbbVie’s Qulipta (atogepant) as First Oral CGRP Receptor Antagonist for Preventive Treatment of Episodic Migraine in Adults

Compiled & Translated by | Tom Li

Recently, AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. Consequently, Qulipta has become the first and only calcitonin gene-related peptide (CGRP) receptor antagonist specifically indicated for the preventive treatment of migraine, and it requires only once-daily oral administration.

The approval of this oral CGRP antagonist was supported by robust data from a clinical program that evaluated the efficacy, safety, and tolerability of Qulipta in nearly 2,000 patients experiencing a mean of 4 to 14 migraine days per month. Results from the pivotal Phase 2b/3 trial demonstrated that all three Qulipta treatment arms met the primary efficacy endpoint of change from baseline in mean monthly migraine days over the 12-week treatment period, showing a significant reduction compared to placebo. Additionally, the trial met its secondary efficacy endpoint, with patients receiving Qulipta demonstrating a significant improvement in mean monthly headache days compared to baseline.

In the pivotal, multicenter, randomized, double-blind, placebo-controlled ADVANCE Phase 3 trial, the reduction in mean monthly migraine days was statistically significant compared with placebo, with patients receiving 60 mg of Qulipta over 12 weeks experiencing a decrease in migraine days from baseline to 4.2 days. A key secondary endpoint in the ADVANCE trial measured the proportion of patients achieving a ≥50% reduction in monthly migraine days during the 12-week treatment period. Results showed that 56%, 59%, and 61% of patients in the 10 mg, 30 mg, and 60 mg Qulipta groups, respectively, achieved a 50% to 100% reduction, compared with only 29% in the placebo group.

In the trial, all Qulipta dose groups demonstrated good tolerability. Common adverse events (incidence ≥2%) included nausea (5–9% vs. 3% for placebo), constipation (6% vs. 1%), fatigue/somnolence (4–6% vs. 3%), and decreased appetite (1–2% vs. <1%). The adverse events most frequently leading to discontinuation were constipation (0.5%), nausea (0.5%), and fatigue or somnolence (0.5%). Study investigator Peter J. Goadsby stated that the convenience of oral administration, rapid onset of action, safety, and tolerability of Qulipta, along with the high patient response rate to treatment, represent a milestone in preventive migraine therapy.

Migraine is a complex disease characterized by recurrent, often disabling attacks, featuring severe, pulsating headaches and complex associated symptoms, such as extreme sensitivity to light and sound, or nausea. The condition is highly prevalent, affecting over 1 billion people worldwide, including 39 million in the United States alone, and is the leading cause of disability globally among individuals under 50 years of age. The approval of Qulipta provides a simple and convenient oral treatment option for this patient population.

Qulipta is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) initially developed specifically for the preventive treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system involved in the pathophysiology of migraine. Research indicates that CGRP levels rise during migraine attacks, and selective CGRP receptor antagonists have demonstrated clinical efficacy in migraine management. Michael Severino, Chairman and CEO of AbbVie, stated that millions of migraine patients typically lose several days of productivity each month due to the condition, as the attacks can be debilitating. AbbVie’s Qulipta, administered as a once-daily oral dose, provides rapid and sustained action, helping to reduce the number of migraine days per month for patients.

The newly approved Qulipta is available in three dosage strengths (10 mg, 30 mg, and 60 mg) and is expected to be launched in early October 2021. Notably, AbbVie is now the only pharmaceutical company offering three products in the migraine treatment space. Among them, Botox is the first FDA-approved preventive therapy for chronic migraine in adults, while Ubrelvy is the first FDA-approved oral CGRP receptor antagonist for the acute treatment of migraine (with or without aura) in adults.

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FDA Approves QULIPTA™ (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine