4SC AG, a biotechnology company focused on therapies for advanced-stage cutaneous T-cell lymphoma (CTCL), has been granted a product-specific Paediatric Investigation Plan (PIP) waiver by the UK Medicines & Healthcare products Regulatory Agency (MHRA) for resminostat (Kinselby). This waiver pertains to resminostat's use as an oral maintenance treatment for advanced-stage CTCL.
Significance of the Waiver
The MHRA requires pharmaceutical companies to submit a PIP outlining strategies for investigating new medicines in pediatric populations as part of the regulatory process for new drug registration. A waiver can be granted when development of a medicine for use in children is deemed unnecessary or inappropriate, as is the case with resminostat in advanced-stage CTCL. According to Jason Loveridge, Ph.D., CEO of 4SC, "Receiving this waiver from the MHRA is a significant milestone as it brings 4SC a step closer to advancing our Marketing Authorisation Application for resminostat in the UK, avoiding the significant time and expense required to conduct a paediatric clinical study."
Regulatory Submissions
4SC filed its Marketing Authorisation Application with the European Medicines Agency (EMA) in February 2024, seeking approval for resminostat in the treatment of CTCL in Europe. Furthermore, the company has submitted a pre-New Drug Application (NDA) meeting request to the U.S. Food and Drug Administration (FDA) in February 2024. Filings for the UK and Switzerland are also in preparation.
