Medical Letter on the CDC & FDA
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Drug Development
Orphan drug designation granted for key component in liver assist program
September 5th, 2004
Vital Therapies, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the use of immortalized human liver cells to treat fulminant hepatic failure (acute liver failure). The cells are the biologic component of Vital Therapies' ELAD System (extracorporeal liver assist device), which is currently in clinical development. The ELAD System is designed to provide liver function and support to patients with acute liver failure, thereby enabling the patient's liver to regenerate or function until a suitable donor liver becomes available for transplantation. A patient is treated by continuously passing...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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