Aurinia Launches Its First Drug With Lupkynis Approval For Lupus Nephritis
The calcineurin inhibitor, only the second drug to be approved by the US FDA for lupus nephritis, will be competing against GlaxoSmithKline’s Benlysta.
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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.
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.
Canada’s Aurinia Pharmaceuticals expects to file a US NDA in the first half of next year on the use of its next-generation calcineurin inhibitor, voclosporin, in lupus nephritis, a condition with no approved therapies.