FDA orphan drug status given to Exelixis, Inc. (EXEL) for the Treatment of Hepatocellular Carcinoma
Release Date: 15-Apr-2017
US Food and Drug Administration have granted orphan drug designation to Exelixis’ novel product cabozantinib for the treatment of hepatocellular carcinoma (HCC). A pivotal phase 3 trial (CELESTIAL) of cabozantinib is in process with patients suffering from advanced HCC.
The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
