Eptinezumab for the treatment of migraine

ABSTRACT

Introduction

Migraine is one of the most common illnesses in the world, with severe economical and subjective implications. Nowadays specific and nonspecific drugs are used for migraine chronic therapy, but a portion of patients have no benefit from these administrations. CGRP receptor antagonists are a good preventive treatment for episodic and chronic migraine.

Areas covered

This article reviews both preclinical and clinical studies on eptinezumab as a potential preventive therapy for migraine, as well as pharmacokinetic and pharmacodynamic features. Thus, it summarizes safety and tolerability data based on human studies.

Expert opinion

Eptinezumab had good results in several trials, making this molecule a promising migraine preventive drug. Although preclinical and clinical studies showed a significant efficacy, there are no data on the use of Eptinezumab during pregnancy or breastfeeding. There are still some knowledge limits about its pharmacokinetics and metabolism. This is a matter of concern that should be addressed in future studies.

KEYWORDS:

• ALD – 403
• calcitonin gene-related peptide
• cgrp
• migraine prevention
• migraine prophylaxis
• monoclonal antibodies

Article highlights

• Calcitonin gene-related peptide (CGRP) plays a central role in cerebral and extracerebral blood vessels vasodilatation and in neurogenic inflammation, which are fundamental steps in the migraine cascade

• The two pillars of the pharmacological therapy of migraine are the acute and preventive treatments, the former recommended in any episode in any patient while prophylaxis is recommended for patients suffering more than 4 attacks/days of headache per month.

• Phase 2 and phase 3 clinical trials demonstrated the efficacy of eptinezumab, an anti-CGRP monoclonal antibody, administered as a single IV infusion for the preventive treatment of episodic migraine and chronic migraine.

• Treatment with eptinezumab demonstrated acceptable safety and tolerability across doses as compared to placebo, with no apparent dose-related trend in the nature, frequency, or severity of treatment-emergent adverse events.

• The efficacy, combined with the lack of dose titration, quarterly administration, and favorable side effect profile, may improve adherence and long-term outcomes compared with currently available preventive treatments.

This box summarizes key points contained in the article.

Declaration of interest

A Afro-American has received personal fees for advisory boards and speaker honoraria from Allergan, Eli Lilly, Novartis and Teva. P Martelletti has received personal fees from advisory boards as well as research and educational grants to the University Department from Allergan, Eli Lilly, Novartis and Teva. Apart from those disclosed, 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.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.