On January 7, 2025 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported that it had submitted its responses to the Day-120 List of Questions from the European Medicines Agency (EMA) in December 2024 as planned, following 4SC’s initial Marketing Authorisation Application (MAA) filing for resminostat (Kinselby) in March 2024 (Press release, 4SC, JAN 7, 2025, View Source [SID1234649444]). The EMA has notified 4SC that examination of the Company’s MAA shall continue according to schedule.
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The Day-120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process for resminostat (Kinselby), an orally available treatment for Cutaneous T-cell Lymphoma (CTCL).
Subject to the EMA’s decision, marketing authorisation approval is expected around mid-2025. This filing moves resminostat (Kinselby) another step closer to market following Orphan Drug Designation from the EMA in 2023 and from the Swiss Agency for Therapeutic Products (SwissMedic) in September 2024.
Jason Loveridge, Ph.D., CEO of 4SC, commented: "This filing marks a significant step forward for resminostat (Kinselby) as we progress ever closer to marketing authorisation approval, which is expected in mid-2025. We remain committed to bringing this much needed treatment to patients as soon as possible, and preparations for market launch are ongoing, as well as actively engaging with potential partners interested in commercializing the drug."