BIVI - BioVie gets FDA guidance for BIV201 development program

BioVie (BIVI) highlights feedback from the U.S. FDA related to the company's development program for BIV201 for the treatment of hepatorenal syndrome–acute kidney injury ((HRS-AKI)).Based on communications with the FDA, the company believes that positive results from a single pivotal Phase 3 clinical trial could potentially support the filing of a New Drug Application ((NDA)) and eventual approval of BIV201 for the treatment of HRS-AKI."We greatly appreciate the FDA’s guidance for the HRS-AKI trial design. Based on their feedback, we plan to apply for a Special Protocol Assessment (SPA) to gain agreement on the key elements of the Phase 3 trial design prior to initiating the study," Chief Scientific Officer for liver cirrhosis, Penelope Markham said.Shares up marginally during premarket trading.

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BioVie gets FDA guidance for BIV201 development program