4SC, a biotech company specialising in T-cell lymphoma drug development, has received orphan drug status for its cutaneous T-cell lymphoma (CTCL) targeting therapeutic, resminostat (Kinselby).
This was granted by the Swiss Agency for Therapeutic Products, meaning it will now have reduced regulatory fees and an accelerated review process.
The comes after the European Medicines Agency and the US Food and Drug Administration came to the same conclusion, with both organisations granting resminostat orphan drug designation.
The awarding of orphan drug designation status means that Kinselby will have ten years of market exclusivity in the EU, and seven years in the US.
CEO of 4SC, Jason Loveridge commented: “Receiving orphan drug status in Switzerland builds on the solid foundation of regulatory support that we already have in the EU and US, and will help our efforts to commercialise Kinselby in these major markets.”
