4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA
4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA
- The US Food and Drug Administration (FDA) has granted 4SC’s application for Orphan Drug Designation for resminostat (Kinselby) for cutaneous T cell lymphoma (CTCL)
- Marketing Authorisation Application (MAA) for Kinselby (resminostat) in the EU remains on track for filing in Q1 2024
Planegg-Martinsried, Germany, 27 September 2023 – 4SC AG (4SC, FSE Prime Standard: VSC) received notification that the US Food and Drug Administration (FDA) has granted 4SC’s application for Orphan Drug Designation for resminostat (Kinselby) for cutaneous T cell lymphoma (CTCL).
Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby. We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”
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