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NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. AbbVie anticipates a regulatory decision in late Q3 2021.
Migraine is a complex, chronic disease with attacks that are often incapacitating and can include headache pain as well as neurologic and autonomic symptoms.3 Migraine symptoms and severity range widely among individuals.
The NDA is supported by data from a robust clinical program evaluating the efficacy, safety and tolerability of orally administered atogepant in nearly 2,500 patients who experience 4-14 migraine days per month including but not limited to the pivotal Phase 3 ADVANCE study, the pivotal Phase 2b/3 study, and the Phase 3 long-term safety study.
"With the integration of Allergan, AbbVie is now a committed leader in migraine with an almost 25-year history in migraine research. We look forward to potentially adding a new treatment option to our portfolio that will help more people with migraine," said Michael Gold, MD, vice president, neuroscience development, AbbVie. "We believe atogepant is an advancement with the potential to offer meaningful benefits as a safe, effective oral preventive treatment option. Despite the availability of other migraine treatment options, the medical community and people living with migraine recognize the unmet need of those who face the unpredictable and debilitating realities of this disease."
In the Phase 3 ADVANCE study, all active treatment arms of atogepant met their primary endpoint of a statistically significant reduction in mean monthly migraine days over a 12-week treatment period. Also, the 30 and 60 mg doses met all six secondary endpoints with statistical significance. This study followed positive results from the Phase 2b/3 study that met the same primary endpoint across all doses and dosing regimens. The Phase 3 long-term safety study evaluated safety and tolerability of 60 mg oral atogepant administered daily over 52 weeks. The Phase 3 long-term safety study will be presented at the American Academy of Neurology 2021 Virtual Annual Meeting. Results from the Phase 2b/3 study and the Phase 3 ADVANCE study were previously announced.1,4
About the Phase 3 ADVANCE StudyThe pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of migraine in those with 4 to 14 migraine days per month. A total of 910 patients were randomized to one of four treatment groups evaluating 10 mg, 30 mg, and 60 mg of atogepant once daily, or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population of 873 patients.
The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All atogepant dose groups met the primary endpoint and demonstrated statistically significant reductions in mean monthly migraine days compared to placebo. Patients treated in the 10 mg, 30 mg, and 60 mg atogepant arms experienced a decrease of 3.69, 3.86, and 4.2 days, respectively, compared to patients in the placebo arm, who experienced a decrease of 2.48 days (all dose groups vs. placebo, p=
