Erenumab: First Global Approval

  title={Erenumab: First Global Approval},
  author={Anthony Markham},
  • A. Markham
  • Published 1 July 2018
  • Medicine, Biology
  • Drugs
Amgen and Novartis are developing erenumab (AIMOVIG™, erenumab-aooe)—a fully human monoclonal antibody calcitonin gene-related peptide (CGRP) receptor antagonist—for the prevention of migraine. CGRP is a vasodilatory neuropeptide implicated in the pathophysiology of migraine and treatment with erenumab was associated with significant reductions in migraine frequency in phase II and III clinical trials. Based on these positive results erenumab was recently approved in the US for the preventive… 

Erenumab: A novel calcitonin gene-related peptide receptor antagonist developed specifically for migraine prevention

Erenumab, a calcitonin gene-related peptide receptor inhibitor, is a recent addition to this armamentarium and has shown modestly improved outcomes according to the current trials, however, long-term outcomes and adverse effects still are under research.

Eptinezumab for the preventive treatment of migraine.

The pharmacology of eptinezumab and the four studies that led to the approval, two Phase II and two Phase III clinical trials, are reviewed and demonstrated efficacy, tolerability and safety in patients with episodic and chronic migraine are reviewed.

Cardio- and cerebrovascular safety of erenumab, a monoclonal antibody targeting CGRP receptors – important studies on human isolated arteries

The question remains open whether blockade of the CGRP receptor would have an effect on coronary artery function in women with microvascular disease.

A Review of Eptinezumab Use in Migraine

Eptinezumab is a relatively safe drug for the prevention of migraines with treatment-related adverse events occurring at a low frequency and they bear a safe profile in patients with comorbidities like obesity and type 1 diabetes.

Migraine Prevention with Erenumab: Focus on Patient Selection, Perspectives and Outcomes

The design and results of the main studies on erenumab are reviewed and treatment use in the current migraine prevention scenario is discussed, along with the main ongoing research projects and clinical perspectives for the future are provided.

Calcitonin Gene-Related Peptide Receptor

This activity will highlight the mechanism of action, monitoring, adverse events, relevant interactions, and other key elements in the clinical setting as relates to the essential points needed by members of an interprofessional team managing the care of patients with migraine.

Current status of calcitonin gene-related peptide-based therapies in migraine: a scoping review

Evidence from animal studies elucidated the role of calcitonin gene-related peptide (CGRP) in the pathophysiology of migraine and two classes of drugs were found efficacious and safe in various clinical trials for the treatment and prevention of migraine.

Monoclonal Antibodies Targeting CGRP: From Clinical Studies to Real-World Evidence—What Do We Know So Far?

The latest clinical evidence for the use of anti-CGRP in migraine prevention with emphasis on efficacy and safety outcomes from Phase III and real-world studies is provided.

Pharmacokinetics and Safety of Erenumab after a Single Subcutaneous Injection Dose in Healthy Chinese Subjects

Erenumab was safe and well tolerated after a single subcutaneous injection in healthy Chinese subjects and the systemic exposure in Chinese subjects in terms of AUC0-∞ was 70% higher than that in White subjects as previously reported.

The impact of CGRPergic monoclonal antibodies on prophylactic antimigraine therapy and potential adverse events

This review considers the current knowledge on the mechanisms of action, specificity, safety, and efficacy of the above mAbs as prophylactic antimigraine agents, and examines the possible adverse events that these agents may trigger.



A Controlled Trial of Erenumab for Episodic Migraine

Erenumab administered subcutaneously at a monthly dose of 70 mg or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities, and the use of acute migraine–specific medication over a period of 6 months.

Erenumab (AMG 334) in episodic migraine

This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life and safety.

Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study

This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life and supports further investigation of erenUMab as a preventive treatment in patients with EM.

Phase I, Randomized, Double‐blind, Placebo‐controlled, Single‐dose, and Multiple‐dose Studies of Erenumab in Healthy Subjects and Patients With Migraine

The results indicate that the PK profile of erenumab is nonlinear from 1 mg to 70 mg and the linear portion of the clearance from 70 mg to 210 mg is consistent with other human immunoglobulin G2 antibodies.

Pharmacologic Characterization of AMG 334, a Potent and Selective Human Monoclonal Antibody against the Calcitonin Gene-Related Peptide Receptor

Results indicate AMG 334 is a potent, selective, full antagonist of the CGRP receptor and show in vivo dose-dependent target coverage in cynos, currently in clinical development for the prevention of migraine.

Efficacy and safety of erenumab in episodic migraine patients with 2–4 prior preventive treatment failures: results from the Phase 3b LIBERTY study [abstract no. 009

  • American Academy of Neurology 70th Annual Meeting
  • 2018

ARISE: A Phase 3 randomized trial of erenumab for episodic migraine

As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use.

Erenumab (Aimovig™): US prescribing information