Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union
Jason Loveridge, Ph.D., CEO of 4SC, commented: “CTCL is currently an incurable disease and patients are in great need of better therapies. Our recent RESMAIN trial has demonstrated strong efficacy data for resminostat (Kinselby). Receiving orphan drug designation provides us with a number of important benefits for resminostat (Kinselby), most crucially 10 years’ market exclusivity in the European Union, and, alongside our Orphan Drug Designation in the US, provides us with a solid foundation for our efforts to commercialise Kinselby in these major markets.”
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