BioVie’s New Drug Candidate BIV201 Receives FDA Orphan Drug Designation for the Treatment of Hepatorenal Syndrome (HRS)
About BIV201
BIV201 (continuous infusion terlipressin) represents a potential new treatment option for thousands of patients suffering from ascites, HRS, and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, nonalcoholic steatohepatitis (NASH), and alcoholism. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically for treating ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis, but is not available in the US or Japan. In addition to Orphan Drug designations for ascites and HRS, BIV201 has FDA Fast Track status and US patent protection. For more information about BioVie, please visit our website: www.biovieinc.com.
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SOURCE: BioVie Inc.