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BioVie secures FDA's fast track designation for liver disease complication drug

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BioVie secures FDA's fast track designation for liver disease complication drug

The U.S. Food and Drug Administration granted fast track designation to BioVie Inc.'s BIV201 for the treatment of refractory ascites, or the accumulation of protein-containing fluid in the abdomen, due to liver cirrhosis.

There are no drug therapies approved by the FDA to treat ascites specifically.

BioVie is evaluating the safety and indicator for potential efficacy of BIV201 in a phase 2a trial.