by Dr. C.H. Weaver M.D. 4/2019
The Food and Drug Administration (FDA) has approved the intravenous (IV) formulation of Benlysta (belimumab) for the treatment of pediatric patients ≥5 years old with active, autoantibody-positive, systemic lupus erythematosus (SLE).
Benlysta is a B-lymphocyte stimulator (BLyS)-specific inhibitor, was previously approved for the treatment of adult patients with active, autoantibody-positive, SLE who are receiving standard therapy. The treatment is available for IV and subcutaneous (SC) administration, however the SC formulation is only approved for use in adults.
The FDA approval was based on data from the “PLUTO” clinical trial which evaluated Benlysta IV plus standard therapy in 93 pediatric patients with SLE. (2)
Results showed that more patients treated with Benlysta IV plus standard therapy improved compared with those who received placebo plus standard therapy. In addition, flare severity and duration were also improved in patients treated with Benlysta IV compared with placebo.
Commenting on the approval, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research said, “The agency expedited the review and approval of this application because Benlysta IV fulfills an unmet need for therapies, specifically in pediatric patients with SLE.”