FDA Approves Benlysta from GSK for Active Lupus Nephritis

The FDA has approved GlaxoSmithKline’s (GSK) Benlysta (belimumab) for treating active lupus nephritis, a serious inflammation of the kidneys that appears in about four in 10 patients with the most common form of lupus.

The approval was based on results from a phase 3 study in 448 adult patients with active lupus nephritis, in which a statistically significant greater number of patients improved at 104 weeks when treated with Benlysta plus standard therapy compared to the group that received a placebo plus standard therapy.

Benlysta was first approved in 2011 for patients with systemic lupus erythematosus receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives and nonsteroidal anti-inflammatory drugs.