Calliditas Therapeutics (CALT) TARPEYO Granted FDA Approval
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FDA grants Calliditas Therapeutics Accelerated Approval of TARPEYO™ (budesonide) to Reduce Proteinuria in IgA Nephropathy
December 15, 2021 5:04 PM ESTSTOCKHOLM, Dec. 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) 1.5g/g. This indication is approved under accelerated approval. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval may be contingent upon verification and description... More
