Diabetic Nephropathy

Assessment agreement with U.S. FDA for diabetic nephropathy trials finalized

Published in Medical Letter on the CDC and FDA, April 17th, 2005

Keryx Biopharmaceuticals, Inc. (KERX) announced that it has finalized a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the phase 3 and phase 4 clinical trials of KRX-101 (sulodexide gelcaps), the company's drug candidate for treating diabetic nephropathy.

The clinical plan to support a new drug application (NDA) approval for KRX-101 under Subpart H (accelerated approval), as agreed upon with the FDA under an SPA, consists of (i) a single phase 3 trial in patients with microalbuminuria based on the surrogate marker of regression of microalbuminuria as the primary endpoint; (ii) supportive data from previously conducted...

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Source: Medical Letter on the CDC and FDA (2005-04-17)

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