ChemoCentryx announces FDA orphan drug designation for Avacopan in the Treatment of Debilitating Kidney Disease C3 Glomerulopathy (C3G)
US Food and Drug Administration (FDA) have announced orphan drug designation for chemocentryx’s .
Release Date: 05-Apr-2017
US Food and Drug Administration (FDA) have announced orphan drug designation for chemocentryx’s leading product candidate, avacopan for the treatment of patients suffering with Debilitating Kidney Disease C3 Glomerulopathy (C3G). ChemoCentryx, Inc. is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer.
C3G is a severe kidney disease characterized by deposits of proteins from the body’s complement system into and around the kidney’s filtration units, the glomeruli. The deposition of complement protein disrupts kidney function and also triggers a profoundly destructive inflammation of the kidney. The disease process ultimately leads to renal failure, with the need for dialysis and kidney transplant.
Avacopan is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR. Action of mechanism for avacopan suggests targeting the complement C5a receptor (C5aR) which drives the destructive inflammatory cells in C3G and other kidney diseases. In this way, avacopan is designed to arrest the ongoing process of kidney damage in C3G, allowing kidney function to stabilize.
FDA Orphan Drug Designation is granted to investigational therapies that address rare medical diseases or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug status provides benefits to drug developers including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
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