Keryx KRX-101 subpart H development plan
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Keryx Biopharmaceuticals fast track diabetic nephropathy therapy KRX-101 will be submitted under subpart H, firm announces Nov. 13. The development plan allows use of surrogate endpoints in a single pivotal Phase III trial to support KRX-101's approval. Keryx is reviewing feedback from FDA and hopes to initiate the trial early next year. The firm expects the Cardio-Renal advisory committee to review the development pla
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