Checkpoint Therapeutics, Inc. announced that it has received Pediatric Investigation Plan (PIP) product-specific waivers from the European Medicines Agency (EMA) and the U.K. Medicines & Healthcare products Regulatory Agency (MHRA) for cosibelimab in cutaneous squamous cell carcinoma (cSCC). Following the announcement of positive topline data from Checkpoint's registration-enabling clinical trial in January 2022, aU.S. Biologics License Application (BLA) submission for cosibelimab is planned for later this year, to be followed by marketing authorization applications (MAAs) in Europe. The regulatory processes for the registration of new medicines with the EMA and MHRA require pharmaceutical companies to provide a PIP outlining their strategy for investigating the new medicine in a pediatric population.

In some instances, a waiver may be granted by the respective regulatory authority when the development of a medicine for use in children is not feasible or appropriate, as is the case for cosibelimab in cSCC.