FDA grants orphan drug designation to 4SC cancer treatment

PLANEGG-MARTINSRIED, Germany — The Food and Drug Administration has granted orphan drug designation to a cancer treatment in mid-stage development made by German drug maker 4SC, the company said Tuesday.

4SC announced that it received the designation for resminostat, currently in phase-2 clinical trials as a treatment for hepatocellular cancer, or HCC. The FDA grants orphan drug designation to drugs for diseases that affect fewer than 200,000 people in the United States.

HCC is a liver cancer resulting from hepatitis infection and liver cirrhosis due to alcoholism. Despite its relative rarity in North America and Europe, it is the world’s sixth most common cancer and the third-leading cause of cancer-related death, with a particularly high prevalence in Southeast Asia due to high rates of hepatitis B infections in the region.

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