First Drugs For Lupus Nephritis Are Headed For US FDA Review
Two drugs that would be the first for lupus nephritis are on the doorstep of the US FDA, a novel drug voclosporin from Aurinia Pharmaceuticals and Benlysta from GlaxoSmithKline.
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The calcineurin inhibitor, only the second drug to be approved by the US FDA for lupus nephritis, will be competing against GlaxoSmithKline’s Benlysta.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The new indication paves the way for Benlysta in a new patient population, as well as expansion in systemic lupus erythematosus, US specialty unit head Sheri Mullen said.