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The US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for use in active, autoantibody‑positive Systemic Lupus Erythematosus (SLE) patients. While the intravenous formulation was first approved in 2011, this becomes the first subcutaneous injectable treatment option SLE.
Patient may now receive a once weekly injection of 200mg, from either a single-dose prefilled syringe or from a single-dose autoinjector.
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).
Benlysta subcutaneous formulation will be available in specialty pharmacies in the US in late August.
Benlystas worldwide sales were $398 million in 2016, with over 90% of sale from the USA.