FDA Approves Self-Injectable Form of Benlysta for Systemic Lupus Erythematosus

Patients will be able to avoid hour-long infusions at health care facilities

Patients receiving belimumab for the treatment of systemic lupus erythematosus (SLE) will soon be able to administer injections of the drug at home rather than visiting a hospital or clinic for an hour-long intravenous infusion.

The FDA has approved a new subcutaneous formulation of belimumab (Benlysta, GlaxoSmithKline) for the treatment of adults with active, autoantibody-positive SLE who are receiving standard therapy. SLE is the most common form of lupus, a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body. 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 10 mg/kg, via a one-hour infusion in a hospital or clinic setting every four 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 U.S. in late August.

Benlysta is currently the only medicine specifically developed and approved for SLE. Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Benlysta does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

Source: GlaxoSmithKline; July 21, 2017.