BioVie announced the FDA granted the company a fast track designation for their orphan drug candidate BIV201.
BioVie (OTCQB:BIVI) announced the US Food and Drug Administration (FDA) granted the company a fast track designation for their orphan drug candidate BIV201.
As quoted in the press release:
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.
The FDA’s Fast Track program is designed to facilitate development and expedite the review of drug candidates that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Fast Track designation allows for more frequent communications with the FDA to discuss the clinical development program and review process. Upon submission of a marketing application, drug candidates with Fast Track designation ordinarily qualify for priority review, thereby expediting the FDA review process.