On December 20, 2017 4SC AG (4SC, FSE Prime Standard: VSC) reported that it received a Pediatric Investigation Plan waiver from the European Medicines Agency (EMA) for resminostat in advanced-stage cutaneous T-cell lymphoma (CTCL) (Press release, 4SC, DEC 20, 2017, View Source [SID1234522733]).

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As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a Pediatric Investigation Plan that outlines the clinical development strategy for studying the investigational product in children. In some instances, a waiver from developing a Pediatric Investigation Plan for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate. CTCL is extremely rare in children and if present, is usually an early stage disease that can be controlled quite well with existing therapies.

"This waiver represents an important milestone in the regulatory process for resminostat, and will allow 4SC to submit a Marketing Authorization Application for resminostat to the EMA following successful completion of the pivotal RESMAIN study without the requirement to conduct additional clinical studies in children before or after approval," said Jason Loveridge, CEO of 4SC.

Resminostat is being evaluated as maintenance therapy in advanced-stage CTCL patients in the pivotal RESMAIN study, which is currently being conducted at more than 50 clinical centers in 11 European countries. Top-line results are expected to be available in the first half of 2019.