BioVie’s New Drug Candidate BIV201 Receives FDA Orphan Drug Designation
BioVie’s New Drug Candidate BIV201 Receives FDA Orphan Drug Designation for the Treatment of Hepatorenal Syndrome (HRS) November 28, 2018 LOS ANGELES, CA / ACCESSWIRE / November 28, 2018 / BioVie Inc. (OTCQB: BIVI) ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for liver disease, announced today that the US Food and Drug Administration (FDA) has granted an Orphan Drug designation to BioVie for terlipressin for the treatment of hepatorenal syndrome (HRS). BIV201 is a new drug candidate currently being tested in a mid-stage (Phase 2a) clinical study in patients with refractory ascites due to advanced liver cirrhosis. The Company previously secured an Orphan Drug designation for terlipressin for treating ascites, and is exploring additional Orphan designation opportunities."An estimated 12,000 to 33,000 Americans develop HRS each year," said BioVie CEO Terren Peizer. "Our novel drug candidate BIV201 could potentially become an [...]