FDA approves subcutaneous formulation of Benlysta (belimumab) for systemic lupus erythematosus- GlaxoSmithKline

The FDA has approved a new subcutaneous formulation of Benlysta (belimumab), from GlaxoSmithKline, for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. The approval marks the first subcutaneous self-injection treatment option for patients with SLE.

The approval is based on data from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE, which measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus).

Comment: Benlysta was approved by European regulators in 2011 for autoantibody-positive SLE, but was only cleared by NICE for routine NHS use in June 2016. Further regulatory submissions for the subcutaneous formulation of Benlysta are under review or planned in other countries during the course of 2017.