GSK Asks US and Europe to Approve Benlysta as Injectable Treatment for SLE

GlaxoSmithKline (GSK) announced that it has filed applications with U.S. and European regulatory agencies to extend the approval of  Benlysta (belimumab) as a treatment for active, autoantibody-positive systemic lupus erythematosus (SLE) to its newer, subcutaneous formulation. The applications draw on positive results from a Phase 3 study in SLE patients treated by injection with the drug.

Benlysta is a human monoclonal antibody that selectively targets B-lymphocyte stimulator (BLyS) – a key element in the survival of immune B-cells – and is currently approved for use as an intravenous (IV), one-hour infusion to be taken every four weeks. Benlysta was approved in this formulation in both Europe and the U.S. in 2011.

A Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for approval of Benlysta injection to treat adult patients with active, autoantibody-positive SLE who are receiving standard therapy; and an extension Marketing Authorization Application (MAA) was filed with the European Medicines Agency (EMA) for it as an add-on therapy in adults with active autoantibody-positive SLE who have a high degree of disease activity.

Both submissions seek approval for Benlysta’s subcutaneous formulation in two forms – a single-dose prefilled syringe and a singe-dose autoinjector.

The clinical study, called  BLISS-SC (NCT01484496),  was double-blind, placebo-controlled evaluation of Benlysta, 200 mg, administrated weekly via subcutaneous injection in addition to standard of care, versus placebo plus standard of care, in almost 840 patients with active, autoantibody-positive SLE.

Results showed that after 52 weeks of treatment, significantly more patients in the Benlysta group (60.8%) exhibited reduced disease activity compared to the placebo group (48.47%). Moreover, the time to the first severe SLE flare was significantly delayed in the Benlysta group (170 days) compared to the placebo group (116.5 days).

“Lupus is a complex and debilitating disease, mainly affecting women of working age, and its symptoms and impact vary from person to person,” Paul-Peter Tak, chief immunology officer and senior vice president of GSK’s Research & Development pipeline, said in a press release. “If approved, a subcutaneous formulation of Benlysta would provide an alternative approach to treatment administration, helping to address the individual needs of lupus patients.”

Similar regulatory filings with agencies in other countries are expected this year and next, the company said.