Subcutaneous form of Benlysta (belimumab) filed in EU and US for systemic lupus erythematosus- GlaxoSmithKline

GlaxoSmithKline has filed regulatory submissions in the US and Europe for Benlysta (belimumab) for approval as a subcutaneous formulation in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). The submissions comprise a Biologics Licence Application (BLA) to the FDA for belimumab administered subcutaneously for the treatment of adult patients with active, autoantibody?positive SLE who are receiving standard therapy, and an extension Marketing Authorisation Application (MAA) to the European Medicines Agency for belimumab administered subcutaneously as add-on therapy in adult patients with active autoantibody-positive SLE with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy.

The regulatory submissions for the subcutaneous formulation in the US and Europe are based on results from the BLISS-SC Phase III pivotal study, which evaluated belimumab 200mg administered weekly via subcutaneous injection plus standard of care (SoC) compared to placebo plus SoC, in patients with active autoantibody-positive SLE.