Fremanezumab for the preventive treatment of migraine.

Introduction: The recent approval of monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway introduced the first preventive treatments for migraine that were specifically designed to target the underlying pathophysiology of the disease. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) administered via subcutaneous injection, is the first approved monoclonal antibody that targets the CGRP ligand and offers both quarterly (once every 3 months) and monthly dosing. Areas covered: An introduction to migraine, overview of the migraine preventive treatments that target CGRP or its receptor, background on CGRP, and details on the fremanezumab clinical development program in both chronic and episodic migraine. Focus is on the Phase 2b and Phase 3 studies, as well as the recently completed long-term Phase 3 study. Expert opinion: The approval of the first disease-specific preventive treatments for migraine heralds a new era in the treatment of migraine. Fremanezumab has a favorable efficacy and safety profile, which is maintained over the long term. Data from patient subgroups with more-complex disease are promising, and an ongoing study in treatment-refractory patients is evaluating the efficacy of fremanezumab in patients who have failed on multiple prior therapies.

RCT Entities:   Population Interventions Outcomes