Actemra Approval History
FDA Approved: Yes (First approved January 8, 2010)
Brand name: Actemra
Generic name: tocilizumab
Dosage form: Injection
Company: Genentech USA, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Giant Cell Arteritis
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; and CAR T cell-induced severe or life-threatening cytokine release syndrome.
Development History and FDA Approval Process for Actemra
|Nov 26, 2018|| FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled Autoinjector|
|Sep 13, 2018|| FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)|
|May 14, 2018|| FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis|
|Aug 31, 2017|| FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome|
|May 22, 2017|| FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis|
|Oct 22, 2013|| 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|| FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis|
|Apr 17, 2011|| FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)|
|Jan 5, 2011|| FDA Grants Supplemental Approval for Actemra (tocilizumab)|
|Jan 11, 2010|| 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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