FDA grants orphan drug status to MIV-818 for hepatocellular carcinoma
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The FDA granted orphan drug designation to MIV-818 for the treatment of hepatocellular carcinoma.
MIV-818 (Medivir AB) is a pro-drug designed to selectively treat liver cancer cells and minimize side effects.
If approved, it could become the first liver-targeted, orally administered drug for patients with HCC, according to a Medivir-issued press release.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.