The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for atogepant to prevent migraine in adults who meet criteria for episodic migraine.
The NDA includes data from several studies evaluating the efficacy, safety, and tolerability of atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, in roughly 2500 patients with episodic migraine (4-14 migraine days per month).
Findings from the phase 3 ADVANCE study (ClinicalTrials.gov: NCT03777059) demonstrated statistically significant reductions in mean monthly migraine days with atogepant when compared with placebo (primary endpoint). Positive results were also reported from a phase 2b/3 study (ClinicalTrials.gov: NCT02848326), which met the same primary endpoint across all doses and dosing regimens. Results of a phase 3 long-term safety study (ClinicalTrials.gov: NCT04686136) will be presented at the American Academy of Neurology 2021 Virtual Annual Meeting.
“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,” 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.”
The FDA is expected to make a decision on the application by the third quarter of 2021.
U.S. FDA accepts AbbVie’s New Drug Application for atogepant for the preventive treatment of migraine. [press release]. Chicago, IL: AbbVie; March 30, 2021.