On July 16, 2024 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage CTCL, reported to have received notification from the Swiss Agency for Therapeutic Products (SwissMedic) that it has granted Orphan Drug Status to resminostat for the treatment of CTCL (Press release, 4SC, JUL 16, 2024, View Source [SID1234644874]).

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In Switzerland, ODS provides privileged status to drugs that show promise for the treatment of rare diseases and this qualifies 4SC for benefits including fee reductions and a faster review process.

This follows previous announcements that both the European Medicines Agency and the US Food and Drug Administration had granted resminostat (Kinselby) orphan drug designation. This gives a number of benefits, most importantly ten and seven years’ market exclusivity respectively in the EU and US.

Jason Loveridge, Ph.D., CEO of 4SC, 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."