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, 2021||Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children|
|Mar 4, 2021||Approval 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, 2018||Approval FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled Autoinjector|
|Sep 13, 2018||Approval FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)|
|May 14, 2018||Approval FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis|
|Aug 31, 2017||Approval FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome|
|May 22, 2017||Approval FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis|
|Oct 22, 2013||Approval 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, 2013||Approval FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis|
|Apr 17, 2011||Approval FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)|
|Jan 5, 2011||Approval FDA Grants Supplemental Approval for Actemra (tocilizumab)|
|Jan 11, 2010||Approval FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis|
|Dec 4, 2008||Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)|
|Sep 18, 2008||FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application|
|Jul 29, 2008||FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis|
|Nov 21, 2007||Roche Submits Application for FDA Approval of Actemra for theTreatment of Rheumatoid Arthritis|
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