Benlysta FDA-Approved as New Self-Injectable Formulation
GlaxoSmithKline announced that the Food and Drug Administration (FDA) has approved Benlysta (belimumab) in a new subcutaneous (SC) injection formulation for the treatment of adults with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. This approval makes Benlysta the first SC self-injection option for patients with SLE.
Benlysta was initially approved as an intravenous (IV) formulation in 2011 and is given in a hospital or clinic as a weight-dosed infusion every 4 weeks. Patients can now self-administer Benlysta as a once weekly SC injection of 200mg from either a single-dose prefilled syringe or from a single-dose autoinjector after being trained by their healthcare provider.
The FDA approval was supported by data from the BLISS-SC Phase 3 study (n>800) in patients with active SLE. The study assessed reduction in disease activity at Week 52 in patients receiving Benlysta + standard of care vs. placebo + standard of care, as measured by the composite measure SRI.
Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS; it does not bind B cells directly. By binding BLyS, it inhibits the survival of B cells, including autoreactive B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
The new SC formulation is anticipated to launch in specialty pharmacies in late August. Benlysta is already available as a 120mg/vial and 400mg/vial strength powder for IV infusion after reconstitution and diltuion.
For more information call (888) 285-5249 or visit Benlysta.com.