Overview

Sarilumab is a fully human anti-interleukin 6 (IL-6) receptor monoclonal IgG1 antibody that binds to both membrane-bound and soluble IL-6 receptor forms, thus blocking the cis- and trans-inflammatory signalling cascades of IL-6. Sarilumab was developed by Sanofi and Regeneron Pharmaceuticals, Inc; it was US FDA-approved in May 2017 and followed by EU approval in June 2017 for the treatment of moderate to severe rheumatoid arthritis (RA) in combination with methotrexate. RA is a chronic inflammatory disease characterized by polyarthritis, and its treatment has been challenged by the different responses in every patient. Subcutaneous administration of sarilumab has been shown to decrease acute-phase reactant levels and improve clinical RA symptoms.

Indication

Sarilumab is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs); and adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

Associated Conditions

Polymyalgia Rheumatica (PMR)
Moderate, active Rheumatoid arthritis
Severe, active Rheumatoid arthritis

Research Report

Published: Aug 4, 2025

Sarilumab (Kevzara): A Comprehensive Clinical and Pharmacological Monograph

Section I: Executive Summary and Drug Profile

Sarilumab is a sophisticated biologic therapy that represents a significant advancement in the management of several autoimmune inflammatory diseases. Developed as a high-affinity, targeted agent, it has established a distinct clinical profile supported by a robust program of pharmacological and clinical research. This monograph provides an exhaustive analysis of Sarilumab, synthesizing data on its molecular characteristics, pharmacological activity, clinical efficacy and safety across its approved indications, and its strategic position within the contemporary therapeutic landscape.

Sarilumab is a biotech drug classified as a fully human immunoglobulin G1 (IgG1) monoclonal antibody.[1] It functions as a potent and specific interleukin-6 (IL-6) receptor antagonist, placing it in the therapeutic classes of disease-modifying antirheumatic drugs (DMARDs) and immunomodulators.[3] Its core mechanism involves binding with high affinity to both soluble and membrane-bound forms of the IL-6 receptor alpha subunit (IL-6Rα), thereby competitively inhibiting the pro-inflammatory signaling cascades mediated by the cytokine IL-6.[1]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer	2025/01/22	NCT06787612	Phase 2	Recruiting	Regeneron Pharmaceuticals
A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.	2023/01/30	NCT05704634	Phase 1	Active, not recruiting	M.D. Anderson Cancer Center
Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation	2022/09/10	NCT05535738	Phase 2	Recruiting	John Harris
Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma	2022/06/22	NCT05428007	Phase 2	Recruiting	NYU Langone Health
A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer	2021/11/18	NCT05125016	Phase 1	Recruiting	Regeneron Pharmaceuticals
Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis	2021/04/13	NCT04842981	Phase 1	Terminated	University of Southern Denmark
Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19	2020/12/10	NCT04661527	Phase 2	UNKNOWN	Clinica Universidad de Navarra, Universidad de Navarra
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab	2020/10/19	NCT04590326	Phase 1	Recruiting	Regeneron Pharmaceuticals
Study on the Use of Sarilumab in Patients With COVID-19 Infection	2020/05/13	NCT04386239	Early Phase 1	Withdrawn	ASST Fatebenefratelli Sacco
Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID)	2020/04/22	NCT04357808	Phase 2	Completed	Maria del Rosario Garcia de Vicuña Pinedo

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
KEVZARA	Sanofi-Aventis U.S. LLC	0024-5910	SUBCUTANEOUS	200 mg in 1.14 mL	2/28/2023
KEVZARA	sanofi-aventis U.S. LLC	0024-5910	SUBCUTANEOUS	200 mg in 1.14 mL	2/28/2023
KEVZARA	Sanofi-Aventis U.S. LLC	0024-5920	SUBCUTANEOUS	150 mg in 1.14 mL	2/28/2023
KEVZARA	sanofi-aventis U.S. LLC	0024-5920	SUBCUTANEOUS	150 mg in 1.14 mL	2/28/2023
KEVZARA	Sanofi-Aventis U.S. LLC	0024-5922	SUBCUTANEOUS	200 mg in 1.14 mL	2/28/2023
KEVZARA	sanofi-aventis U.S. LLC	0024-5922	SUBCUTANEOUS	200 mg in 1.14 mL	2/28/2023
KEVZARA	Sanofi-Aventis U.S. LLC	0024-5908	SUBCUTANEOUS	150 mg in 1.14 mL	2/28/2023
KEVZARA	sanofi-aventis U.S. LLC	0024-5908	SUBCUTANEOUS	150 mg in 1.14 mL	2/28/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Kevzara	Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,FRANCE	Authorised	6/23/2017

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
KEVZARA	sanofi-aventis canada inc	02472988	Solution - Subcutaneous	200 MG / 1.14 ML	6/21/2018
KEVZARA	sanofi-aventis canada inc	02460521	Solution - Subcutaneous	150 MG / 1.14 ML	3/29/2017
KEVZARA	sanofi-aventis canada inc	02472961	Solution - Subcutaneous	150 MG / 1.14 ML	6/21/2018
KEVZARA	sanofi-aventis canada inc	02460548	Solution - Subcutaneous	200 MG / 1.14 ML	2/8/2017

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
KEVZARA 200 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Sanofi Winthrop Industrie	1171196007	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
KEVZARA 150 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Sanofi Winthrop Industrie	1171196001	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
KEVZARA 150 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Sanofi Winthrop Industrie	1171196005	SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
KEVZARA 200 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Sanofi Winthrop Industrie	1171196003	SOLUCIÓN INYECTABLE	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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