Fremanezumab for the preventive treatment of migraine

ABSTRACT

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.

Trial registration: ClinicalTrials.gov identifier: NCT02021773.

Trial registration: ClinicalTrials.gov identifier: NCT02025556.

KEYWORDS:

• Chronic migraine
• calcitonin gene-related peptide (CGRP)
• episodic migraine
• fremanezumab
• preventive treatment

Box 1. Drug summary box.

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Article Highlights

• Migraine is a prevalent neurologic disease, and experts recommend preventive treatment in patients with ≥4 headache days per month and some impairment

• Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway are promising 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 an approved monoclonal antibody that targets the CGRP ligand and offers both quarterly and monthly dosing

• Fremanezumab demonstrated efficacy across all placebo-controlled Phase 2b/3 trials in patients with chronic migraine (CM) or episodic migraine (EM), and in certain patient populations with more-complex disease

• Fremanezumab was generally safe and well tolerated, with low rates of serious adverse events and anti-fremanezumab antibody and anti-fremanezumab neutralizing antibody development in the trials

This box summarizes key points contained in the article.

Acknowledgments

We thank Kristen Hokenson, PhD (Chameleon Communications International with funding from Teva Pharmaceutical Industries Ltd.) for editorial assistance in the preparation of this report.

Declaration of interest

SD Silberstein provides consultation to Alder, Allergan, Amgen, Avanir, Curelater Inc., Depomed, Dr. Reddy’s Laboratories, Ensured Inc., ElectroCore Medical LLC, INSYS Therapeutics, Lilly USA LLC, Supernus Pharmaceuticals Inc., Teva Pharmaceuticals, Theranica, and Trigemina Inc. JM Cohen is an employee of Teva Branded Pharmaceutical Products R&D, Inc. PP Yeung is a former employee of Teva Pharmaceutical Industries Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

One of the reviewers has served on advisory board and travel grants from Allergan, Novartis, TEVA, Amgen, Eli Lilly. Other peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This study was funded by Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.