FDA授予MIV-818肝细胞癌孤药资格

StephenW

FDA grants orphan drug status to MIV-818 for hepatocellular carcinoma
May 6, 2020

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.

StephenW

FDA授予MIV-818肝细胞癌孤药资格
2020年5月6日

FDA授予MIV-818孤儿药治疗肝细胞癌的称号。

MIV-818（Medivir AB）是一种前药，旨在选择性治疗肝癌细胞并使副作用最小化。

根据Medivir发布的新闻稿，如果获得批准，它可能成为第一种针对肝癌的口服肝靶向药物。

FDA孤儿产品开发办公室将孤儿药指定给旨在安全有效地治疗，诊断或预防在美国影响不到20万人的罕见疾病或病症的新药和生物制剂。 该名称使制造商有资格获得各种奖励，包括合格临床试验的税收抵免，以及（经监管部门批准）7年的市场专有权。