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Actemra FDA Approval History

Last updated by Judith Stewart, BPharm on June 28, 2021.

FDA Approved: Yes (First approved January 8, 2010)
Brand name: Actemra
Generic name: tocilizumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Rheumatoid Arthritis; Systemic Juvenile Idiopathic Arthritis (SJIA); Polyarticular Juvenile Idiopathic Arthritis (PJIA); Giant Cell Arteritis; Cytokine Release Syndrome; Systemic Sclerosis-Associated Interstitial Lung Disease

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment rheumatoid arthritis; systemic juvenile idiopathic arthritis (SJIA); polyarticular juvenile idiopathic arthritis (PJIA); giant cell arteritis; CAR T cell-induced severe or life-threatening cytokine release syndrome; and systemic sclerosis-associated interstitial lung disease.

Actemra is also available under an emergency use authorization (EUA) for the treatment of COVID-19 in hospitalized patients 2 years of age and older. Actemra is not FDA-approved for the treatment COVID-19.

Development Timeline for Actemra

Jun 24, 2021Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children
Mar  4, 2021Approval  Genentech’s Actemra Becomes the First Biologic Therapy Approved by the FDA for Slowing the Rate of Decline in Pulmonary Function in Adults With Systemic Sclerosis-Associated Interstitial Lung Disease, a Rare, Debilitating Condition
Nov 26, 2018Approval  FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled Autoinjector
Sep 13, 2018Approval  FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)
May 14, 2018Approval  FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis
Aug 31, 2017Approval  FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome
May 22, 2017Approval  FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis
Oct 22, 2013Approval  Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra for use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis
Apr 30, 2013Approval  FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis
Apr 17, 2011Approval  FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)
Jan  5, 2011Approval  FDA Grants Supplemental Approval for Actemra (tocilizumab)
Jan 11, 2010Approval  FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
Dec  4, 2008Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)
Sep 18, 2008FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application
Jul 29, 2008FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis
Nov 21, 2007Roche Submits Application for FDA Approval of Actemra for theTreatment of Rheumatoid Arthritis

Further information

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