Population Pharmacokinetic Modeling of Fremanezumab in Support of Phase 3 Development for Patients with Migraine
Calcitonin gene-related protein (CGRP) is a well-studied neuropeptide that plays an important role in the pathophysiology of migraines, both centrally and peripherally.1,2 Jugular levels of CGRP are increased during migraine attacks, and intravenous CGRP administration induces migraine-like headaches in most individuals with migraine.3,4 Small-molecule CGRP receptor antagonists and anti-CGRP antibodies have demonstrated efficacy in the treatment of episodic5,6,7,8 migraine (EM) and chronic9 migraine (CM).
Fremanezumab (fully humanized IgG2Δa/kappa monoclonal antibody) is a selective anti-CGRP drug that is being developed for the treatment of migraines. It binds both the α- and β-CGRP isoforms and inhibits CGRP from binding to the CGRP receptor. Also, it does not bind to the closely related amylin, calcitonin, or adrenomedullin peptides. In Phase 2 and 3 studies, fremanezumab has been found to be effective and well-tolerated as a preventive treatment for episodic and chronic migraine.8,10,11
Population Approach Group in Europe (PAGE), May 29 – June 1 2019, Montreux, Switzerland
By Denise Morris, Jill Fiedler-Kelly, M Levi, O Cohen-Barak