4SC AG: Paediatric Investigation Plan waiver for resminostat from the UK MHRA received
- Removes the requirement to conduct paediatric clinical studies when the development of the medicine is not needed or is not appropriate for children
- This supports resminostat’s Marketing Authorisation Application in the UK
Planegg-Martinsried, Germany, 15 April 2024 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma CTCL, today announces that it has received a Paediatric Investigation Plan (PIP) product-specific waiver from UK Medicines & Healthcare products Regulatory Agency (MHRA) for resminostat (Kinselby), an oral maintenance treatment for advanced stage CTCL