AUPH - Aurinia gets FDA approval for lupus nephritis therapy

The FDA has approved LUPKYNISTM (voclosporin) from Aurinia Pharmaceuticals Inc. (AUPH) as a treatment for adults with active lupus nephritis (“LN”) in combination with a background immunosuppressive therapy regimen.Aurinia rose ~14.1% during the five-day period leading up to the FDA action date.The company said that with the approval, voclosporin becomes the first FDA-approved oral therapy for LN, a serious progression of the autoimmune disease SLE, which can eventually lead to irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death.Pivotal studies in patients have indicated that compared to standard of care, voclosporin in combination with standard-of-care have more than doubled the renal response rate with a decline in urine protein creatinine ratio ("UPCR") twice as fast.An estimated ~200 -300K people suffer from SLE in the U.S., with nearly a third of them having LN at the time of SLE diagnosis.In December, Aurinia entered into an agreement with Otsuka

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Aurinia gets FDA approval for lupus nephritis therapy