Home » FDA Approves Benlysta from GSK for Active Lupus Nephritis
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.
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