FDA Approves Self-Dosing Option for GSK’s Benlysta Lupus Treatment

The FDA approved a new subcutaneous formulation of GlaxoSmithKline’s Benlysta (belimumab) for adult patients with active, autoantibody-positive systemic lupus erythematosus, the most common form of lupus.

The 200 mg, once-weekly dose marks the first approval of a subcutaneous self-injection treatment option, according to GSK, available from either a prefilled syringe or from an autoinjector. Benlysta was previously approved as a 10 mg/kg intravenous formulation in 2011.

The approval was based on a Phase III study of more than 800 patients receiving standard care, measuring reduction in disease activity after one year compared to placebo. GSK said the subcutaneous formulation will be available in specialty pharmacies in late August. Regulatory submissions for other countries are under review or planned for later this year.