I. Introduction to product submission Submission details Type of Submission New Biological Entity Initial Decision: Rejected Final Decision: Approved 17 February 2012 Date of Initial Decision: Date of Final Decision: 6 July 2012 Belimumab Active ingredient(s): Product Name(s): Benlysta Sponsor’s Name and Address: GlaxoSmithKline Australia Pty Ltd PO Box 168, Boronia VIC 3155 Dose form(s): Lyophilized powder for intravenous infusion in sterile single-use vials, light. Two configurations of the FDP are available to accommodate dosing 400 mg/vial 5mL deliverable configuration Strength(s): 120 mg/vial 1.5mL deliverable configuration Container(s): Glass flint tubing vial with rubber stopper Pack size(s): 1 vial Approved Therapeutic use: Benlysta is indicated as add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (e.g. ANA titre 1:80 and/or ≥ titre IU/mL) despite standard therapy. ≥30 The safety and efficacy of Benlysta have not been evaluated in patients with severe active nephritis or severe active central nervous system lupus. of administration: Intravenous (IV). ARTG Numbers: 173078 and 173077 Product background This AusPAR describes the application by GlaxoSmithKline Australia Pty Ltd to register a powder for IV infusion containing belimumab, a new, fully human immunoglobulin (IgG1λ) monoclonal antibody. Belimumab was designed to specifically neutralise soluble B
I. Introduction to product submission Submission details Type of Submission New Biological Entity Initial Decision: Rejected Final Decision: Date of Initial Decision: Date of Final Decision: Approved 17 February 2012 6 July 2012 Active ingredient(s): Belimumab Product Name(s): Benlysta Sponsor’s Name and Address: GlaxoSmithKline Australia Pty Ltd PO Box 168, Boronia VIC 3155 Dose form(s): Lyophilized powder for intravenous infusion in sterile single-use vials, light. Two configurations of the FDP are available to accommodate dosing Strength(s): 400 mg/vial 5mL deliverable configuration 120 mg/vial 1.5mL deliverable configuration Container(s): Glass flint tubing vial with rubber stopper Pack size(s): 1 vial Approved Therapeutic use: Benlysta is indicated as add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (e.g. ANA titre ≥ 1:80 and/or titre ≥30 IU/mL) despite standard therapy. The safety and efficacy of Benlysta have not been evaluated in patients with severe active nephritis or severe active central nervous system lupus. of administration: Intravenous (IV). ARTG Numbers: 173078 and 173077 Product background This AusPAR describes the application by GlaxoSmithKline Australia Pty Ltd to register a powder for IV infusion containing belimumab, a new, fully human immunoglobulin (IgG1λ) monoclonal antibody. Belimumab was designed to specifically neutralise soluble B
auspar-belimumab-121031.docx