11 December 2017 - BioVie announced today that the US FDA has granted fast track designation for BIV201 (continuous infusion terlipressin), the Company's patented orphan drug candidate. 

BIV201 is currently being evaluated for the treatment of refractory ascites due to liver cirrhosis in a mid-stage (Phase 2a) US clinical trial, with 2 of the planned 6 patients having been treated with this therapy to date.

BioVie has begun a mid-stage (Phase 2a) clinical trial with its Orphan drug candidate, BIV201, in ascites patients who are refractory to, or intolerant of, diuretic therapy. The trial will take an estimated 6 to 9 months to complete. In addition to evaluating the safety of BIV201 therapy, it will examine indicators of potential efficacy, including ascites fluid volume and the need for paracentesis procedures (the mechanical withdrawal of large amounts of ascites fluid by large bore needle). The study will also evaluate the steady-state pharmacokinetics of terlipressin and its active metabolite. Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT03107091). The safety and efficacy of BIV201 (continuous infusion terlipressin) as a treatment have not been established with the FDA.

Read BioVie press release