4SC AG, a biotech company specialising in developing treatments for advanced-stage cutaneous T-cell lymphoma (CTCL), has announced 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.
The regulatory processes for the registration of new medicines with the MHRA require pharmaceutical companies to provide a PIP outlining their strategy for investigating the new medicine in a paediatric population.
In some instances, a waiver may be granted when the development of a medicine for use in children is not needed or appropriate, as is the case for resminostat in advanced stage CTCL.
Jason Loveridge, Ph.D., CEO of 4SC, commented: “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.”
4SC filed its Marketing Authorisation Application with the European Medicines Agency (EMA) in February 2024, for resminostat for the treatment of CTCL in Europe.
A pre-New Drug Application (NDA) meeting request was submitted to the U.S. Food and Drug Administration (FDA) in February 2024, and there are filings for the UK and Switzerland in preparation.
