Self-Injectable for SLE Gets FDA Nod

JULY 21, 2017
Officials with GSK announced that the US FDA has approved a new subcutaneous formulation of belimumab (Benlysta) 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.

After training from their health care provider, patients will be able to administer the medicine as a once weekly injection of 200 mg, from either a single-dose prefilled syringe or from a single-dose autoinjector. This is the second formulation of Benlysta to be granted approval for SLE, adding to the existing intravenous (IV) formulation, approved in 2011, which is administered by health care professionals to patients as a weight-based dose of 10mg/kg, via a one-hour infusion in a hospital or clinic setting every 4 weeks (following an initial loading phase given on days 0, 14 and 28).

The approval is based on data from the BLISS-SC phase 3 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).

Benlysta subcutaneous formulation will be available in specialty pharmacies in the US in late August.

GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus [news release]. London. GSK website. Accessed at: