Erenumab

Overview

Erenumab (AMG-334) (INN; trade name Aimovig) is a human monoclonal antibody designed specifically to bind and antagonize the calcitonin gene-related peptide receptor (CGRPR) as a means to prevent migraines. Aimovig, as released and marketed by Novartis and Amgen, is in fact a novel therapeutic approach as the first and only FDA approved treatment specifically developed to prevent migraine by blocking the CGRP receptor, which is believed to play a critical role in migraine . In particular, erenumab-aooe is a human immunoglobulin G2 monoclonal antibody that has high affinity binding to the CGRP receptor . The antibody is produced utlilizing recombinant DNA technology in Chinese hamster ovary cells . It is composed of 2 heavy chains, each containing 456 amino acids, and 2 light chains of the lambda subclass, each containing 216 amino acids, with an approximate molecular weight of 150 kDa .

Indication

Erenumab is indicated for the preventative treatment of migraine in adults .

Associated Conditions

Migraine

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain	2024/05/13	NCT06411067	Phase 3	Withdrawn	United States Naval Medical Center, Portsmouth
Migraine Medication Effects on Urinary Symptoms	2024/01/19	NCT06212661	N/A	ENROLLING_BY_INVITATION	The Cleveland Clinic
Aimovig Pregnancy Exposure Registry	2023/11/29	NCT06150781	N/A	Recruiting	Amgen
Screening Trial for Pain Relief in Schwannomatosis (STARFISH)	2023/01/13	NCT05684692	Phase 2	Recruiting	Massachusetts General Hospital
Predictive Role of MIDAS Reduction at 3 Months for Erenumab Treatment	2022/07/01	NCT05442008	N/A	Completed	IRCCS National Neurological Institute "C. Mondino" Foundation
Real World Effectiveness of Eptinezumab in Participants With Migraine	2022/03/17	NCT05284019	Phase 4	Terminated	H. Lundbeck A/S
Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study	2022/03/16	NCT05281770	N/A	Recruiting	Austrian Migraine Registry Collaboration
Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)	2021/12/17	NCT05162027	Phase 2	Terminated	University of Maryland, Baltimore
Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.	2021/12/02	NCT05142228	Phase 2	Terminated	University of Maryland, Baltimore
Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19	2021/09/21	NCT05052008	N/A	Completed	Fayoum University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
AIMOVIG	Amgen Inc	55513-843	SUBCUTANEOUS	140 mg in 1 mL	5/16/2023
AIMOVIG	Amgen Inc	55513-842	SUBCUTANEOUS	140 mg in 1 mL	5/16/2023
AIMOVIG	Amgen Inc	55513-841	SUBCUTANEOUS	70 mg in 1 mL	5/16/2023
AIMOVIG	Amgen Inc	55513-840	SUBCUTANEOUS	70 mg in 1 mL	5/16/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Aimovig	Novartis Europharm Limited,Vista Building,Elm Park, Merrion Road,Dublin 4,Ireland	Authorised	7/26/2018

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 140MG/ML	Amgen Manufacturing Limited (Bulk Production/Primary Packaging)	SIN15926P	INJECTION, SOLUTION	140 MG/ML	4/3/2020
AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED PEN 140MG/ML	Amgen Manufacturing Limited (Bulk Production/Primary Packaging)	SIN15925P	INJECTION, SOLUTION	140 MG/ML	4/3/2020
AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED PEN 70MG/ML	Amgen Manufacturing Limited (Bulk Production/Primary Packaging)	SIN15543P	INJECTION, SOLUTION	70mg/ml	9/21/2018
AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 70MG/ML	Amgen Manufacturing Limited (Bulk Production/Primary Packaging)	SIN15545P	INJECTION, SOLUTION	70mg/ml	9/21/2018

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
AIMOVIG erenumab 140 mg/mL solution for injection in pre-filled pen	309205	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	10/29/2019
AIMOVIG erenumab 140 mg/mL solution for injection in pre-filled syringe	309000	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	10/29/2019
AIMOVIG erenumab (rch) 70 mg/mL solution for injection in pre-filled pen	289959	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	7/2/2018
AIMOVIG erenumab (rch) 70 mg/mL solution for injection in pre-filled syringe	289960	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	7/2/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AIMOVIG	novartis pharmaceuticals canada inc	02487306	Solution - Subcutaneous	140 MG / ML	5/22/2019
AIMOVIG	novartis pharmaceuticals canada inc	02479605	Solution - Subcutaneous	70 MG / ML	N/A
AIMOVIG	novartis pharmaceuticals canada inc	02479613	Solution - Subcutaneous	70 MG / ML	12/4/2018
AIMOVIG	novartis pharmaceuticals canada inc	02487292	Solution - Subcutaneous	140 MG / ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
AIMOVIG 70 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Novartis Europharm Limited	1181293001	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
AIMOVIG 140 MG SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Novartis Europharm Limited	1181293004	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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