Actemra FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 27, 2022.
FDA Approved: Yes (First approved January 8, 2010)
Brand name: Actemra
Generic name: tocilizumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Systemic Sclerosis-Associated Interstitial Lung Disease, Juvenile Idiopathic Arthritis, Cytokine Release Syndrome, COVID-19
Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19.
- Actemra is indicated for the treatment of:
- Rheumatoid Arthritis (RA) - Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
- Giant Cell Arteritis (GCA) - Adult patients with giant cell arteritis.
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) - Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
- Polyarticular Juvenile Idiopathic Arthritis (PJIA) - Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
- Systemic Juvenile Idiopathic Arthritis (SJIA) - Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
- Cytokine Release Syndrome (CRS) - Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.
- COVID-19 - Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The use of Actemra to treat hospitalized people ages 2 to less than 18 years old is not FDA approved and remains under Emergency Use Authorization (EUA).
Development timeline for Actemra
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