medwireNews: The US FDA has approved belimumab as the first drug treatment for adult patients with active lupus nephritis.
Previously approved for systemic lupus erythematosus, the intravenous and subcutaneous formulations of belimumab may now be used in combination with standard therapy for active lupus nephritis.
This approval is based on the results of the phase 3 BLISS-LN trial, which showed that add-on belimumab significantly improves renal outcomes compared with add-on placebo in this patient population.
Commenting on the approval in a press release, BLISS-LN lead investigator Richard Furie (Northwell Health, Great Neck, New York, USA) said that “[w]e have long aspired to enhance outcomes for patients with lupus nephritis,” and “it is gratifying to see the rewards of decades of research.”
The label for belimumab cautions that the B-lymphocyte stimulator-specific inhibitor has not been evaluated in patients with severe active central nervous system lupus, nor in combination with other biologic agents, and should not be used in these situations.
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