Die Europäische Arzneimittelbehörde (EMA) hat dem Antrag von 4SC auf sog. Orphan Drug Designation für Resminostat (Kinselby) für das kutane T-Zell-Lymphom (CTCL) stattgegeben.
Zu den Vorteilen der Orphan Drug Designation gehört eine 10-jährige Marktexklusivität in der Europäischen Union
Der Antrag auf Marktzulassung (MAA) für Kinselby (Resminostat) in der EU wird weiterhin voraussichtlich in Q1 2024 eingereicht
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