CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma
US-based pharmaceutical company CASI (Nasdaq: CASI), which develops therapeutics for the treatment of cancer and other diseases, has received Orphan Drug designation from the US Food and Drug Administration for its orally-active treatment of hepatocellular carcinoma (HCC).
The Aurora A/aniogenic kinase inhibitor, ENMD-2076, has a unique kinase selectivity profile. It has been granted orphan drug status for the treatment of ovarian cancer, multiple myeloma and acute myeloid leukemia.
Orphan Drug designation is granted by the FDA where therapeutics will treat rare diseases, affecting less than 200,000 people in the USA. This designation entitles the sponsor to seven years of market exclusivity, and opportunities for additional funding and expert protocol assistance.
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