A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE).
Phase of Trial: Phase III
Latest Information Update: 27 Sep 2017
At a glance
- Drugs Belimumab (Primary)
- Indications Systemic lupus erythematosus
- Focus Registrational; Therapeutic Use
- Acronyms BLISS-SC
- Sponsors Human Genome Sciences
- 27 Sep 2017 According to a GlaxoSmithKline media release, belimumab (Benlysta) has been approved for the treatment of adult patients with systemic lupus erythematosus (SLE) bu the Japanese Ministry of Health, Labour and Welfare (MHLW) based on results from four trials (Northeas Asia, BLISS-SC, BLISS-52 and BLISS-76).
- 15 Sep 2017 According to a GlaxoSmithKline media release, based on the data of this trial, the regulatory submission is seeking approval for Benlysta subcutaneous formulation in two presentations, a single-dose prefilled syringe and a single-dose autoinjector. A final decision on approval will be made by the European Commission and is expected in the next two to three months. Further regulatory submissions are under review or planned in other countries during the course of 2017.
- 15 Sep 2017 According to a GlaxoSmithKline media release, based on the data of this trial, the Committee for Medicinal Products for Human Use (CHMP) of EMA has issued a positive opinion recommending approval for a new subcutaneous formulation of Benlysta (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus and final decision from the European Commission in the coming months.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History