Lack of Relationship Between Fremanezumab Exposure and Cardiovascular Adverse Events in Phase 2 and Phase 3 Data Including Chronic and Episodic Migraine Patients

Authors: Fiedler-Kelly J, Passarell C, Passarell JA, Faulhaber N, Yeung P, Aycardi E, Cohen-Barak O, Levi M
Conference: AHS
Keywords: adverse events, chronic migraine (CM), episodic migraine (EM), fremanezumab, Kaplan-Meier, PopPK, population modeling
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Objectives

  • Fremanezumab is a fully humanized IgG2Δa/kappa monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP).1
  • Previously, fremanezumab was found to be effective and well-tolerated as a preventive treatment for migraine in 3-month Phase 2 and 3 episodic and chronic migraine studies.2,3,4,5
  • Population-based modeling was used to evaluate the relationships between fremanezumab exposure and the probability of and time to occurrence of selected cardiovascular adverse events (AEs) in patients with episodic migraine (EM) or chronic migraine (CM).

Presented at American Headache Society 60 the Annual Scientific Meeting, June 28-July 1, 2018, San Francisco, CA, USA

Support for this study was provided by Teva Pharmaceuticals, Ltd., Israel

By Jill Fiedler-Kelly, Caroline Passarell, Julie Passarell, Nicola Faulhaber, Paul Yeung, Ernesto Aycardi, Orit Cohen-Barak, and Micha Levi