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Tocilizumab

Generic Name
Tocilizumab
Brand Names
Actemra, RoActemra, Tyenne, Tofidence, Avtozma
Drug Type
Biotech
CAS Number
375823-41-9
Unique Ingredient Identifier
I031V2H011

Overview

Tocilizumab is a recombinant humanized monoclonal antibody IL-6 receptor inhibitor used to treat inflammatory and autoimmune conditions. It was first described in the literature in 2003 when Chugai, a subsidiary of Roche began developing IL-6 inhibiting monoclonal antibodies. Tocilizumab was granted FDA approval on 8 January 2010 to treat a number of inflammatory and autoimmune disorders, such as different types of arthritis and cytokine release syndrome. It was later approved by Health Canada on 30 April 2010. After being investigated to treat severely ill patients with COVID-19, tocilizumab was approved by the European Commission in December 2021 to treat COVID-19 in adults receiving systemic corticosteroids and supplemental oxygen or mechanical ventilation. Subsequently, it was granted approval by Health Canada and the FDA in October and December 2022, respectively. Tocilizumab-bavi, a biosimilar drug, was approved by the FDA in September 2023.

Background

Tocilizumab is a recombinant humanized monoclonal antibody IL-6 receptor inhibitor used to treat inflammatory and autoimmune conditions. It was first described in the literature in 2003 when Chugai, a subsidiary of Roche began developing IL-6 inhibiting monoclonal antibodies. Tocilizumab was granted FDA approval on 8 January 2010 to treat a number of inflammatory and autoimmune disorders, such as different types of arthritis and cytokine release syndrome. It was later approved by Health Canada on 30 April 2010. After being investigated to treat severely ill patients with COVID-19, tocilizumab was approved by the European Commission in December 2021 to treat COVID-19 in adults receiving systemic corticosteroids and supplemental oxygen or mechanical ventilation. Subsequently, it was granted approval by Health Canada and the FDA in October and December 2022, respectively. Tocilizumab-bavi, a biosimilar drug, was approved by the FDA in September 2023.

Indication

Tocilizumab is indicated to treat moderate to severe rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. Tocilizumab is also used to treat coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Associated Conditions

  • Coronavirus Disease 2019 (COVID‑19)
  • Cytokine Release Syndrome caused by CAR-T Cell Therapy
  • Giant Cell Arteritis (GCA)
  • Juvenile Chronic Polyarthritis
  • Moderate to Severe Rheumatoid Arthritis
  • Moderately to Severely Active Rheumatoid Arthritis
  • Polyarticular Juvenile Idiopathic Arthritis
  • Systemic Juvenile Idiopathic Arthritis (SJIA)
  • Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
  • Active systemic Juvenile idiopathic arthritis
  • Severe, active Rheumatoid arthritis

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2022/02/02
Phase 1
Terminated
2022/01/26
Phase 2
Active, not recruiting
2022/01/06
Phase 2
UNKNOWN
2021/12/29
Phase 3
Active, not recruiting
2021/12/27
Phase 1
Recruiting
2021/12/20
Phase 1
Completed
2021/12/13
Phase 1
Completed
2021/11/24
Phase 4
Withdrawn
2021/11/24
N/A
Completed
2021/11/22
Phase 1
Terminated

FDA Approved Products

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No FDA products found for this drug

EMA Approved Products

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HSA Approved Products

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NMPA Approved Products

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PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date
HK-59202
Part 1, Schedule 1 & Schedule 3 Poison
POM
2010/02/08
HK-63771
Part 1, Schedule 1 & Schedule 3 Poison
POM
2015/06/25
HK-59201
Part 1, Schedule 1 & Schedule 3 Poison
POM
2010/02/08
HK-59200
Part 1, Schedule 1 & Schedule 3 Poison
POM
2010/02/08

TGA Approved Products

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