FDA Accepts Atogepant New Drug Application for Preventive Migraine Treatment
The Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for atogepant (AbbVie, Madison, NJ), for preventive treatment of episodic migraine in adults. Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant).
The NDA is support by multiple clinical trials in which close to 2,500 people with 4 to 14 monthly migraine days (MMD), including the pivotal phase 3 ADVANCE trial (NCT03777059) in which 910 participants were randomly assigned to receive 10, 30, or 60 mg of atogepant once daily or placebo. Efficacy analyses were based on a modified intent-to-treat (mITT) population of 873 patients, and all doses of atogepant resulted in statistically significant MMD reductions 3.69, 3.86, and 4.2 days with the 10, 30, and 60 mg dose, respectively, compared with placebo (all dose groups vs. placebo, P<.0001). In addition, 55.6%, 58.7%, and 60.8% of those who received 10, 30, or 60 mg atogepant arms, respectively, achieved at least a 50% reduction in MMD, compared with 29.0% of patients in the placebo arm (all dose groups vs. placebo, P<.0001).
The most common adverse events reported with a frequency ≥ 5% greater than placebo, were constipation (6.9%-7.7% across all doses vs. 0.5% for placebo), nausea (4.4-6.1% across all doses vs. 1.8% for placebo), and upper respiratory tract infection (3.9-5.7% across all doses vs. 4.5% for placebo).
"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."