Surrogate marker and design of Calliditas Therapeutics’ IgA nephropathy Phase 3 study agreed with the FDA
Stockholm, November 20, 2017. Calliditas Therapeutics AB (formerly Pharmalink AB) announced today that the US Food & Drug Administration (FDA) has accepted its Phase 3 study design for its lead candidate Nefecon based on proteinuria as endpoint for accelerated approval. A global Phase 3 program in IgA nephropathy has been initiated, and patient enrolment is expected to start in 2018.The design for the Nefecon Phase 3 study was agreed at the latest meeting with the FDA in September 2017, building on the groundbreaking acceptance of proteinuria as a surrogate marker for accelerated approval,