GlaxoSmithKline's Benlysta earns first FDA approval for lupus nephritis as competitors wait in the wings
When GlaxoSmithKline earned its first approvals back in 2011 for Benlysta, it promised regulators it would keep the ball rolling in its pursuit of lupus nephritis, a severe form of the autoimmune disease that can cause renal failure. Now, nearly a decade after the biologic first hit the market, GSK has made good on that promise.
The FDA on Thursday approved intravenous and subcutaneous Benlysta to treat LN, making it the first therapy ever approved for that indication.
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