Calliditas: SNDA For TARPEYO Granted Priority Review By FDA

(RTTNews) - Calliditas Therapeutics AB (CALT) said the U.S. Food and Drug Administration has accepted the submission for the supplemental New Drug Application or sNDA for TARPEYO delayed release capsules and granted Priority Review. The sNDA is based on the full data set from the Phase 3 NefIgArd clinical trial. The Prescription Drug User Fee Act or PDUFA goal date is 20 December 2023.

TARPEYO is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression.

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