Checkpoint Therapeutics (CKPT) Granted Pediatric Investigational Plan Waivers for Cosibelimab in Europe and UK
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Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT) today 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, a U.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.
"These waivers from the EMA and MHRA are important milestones in the European regulatory process for cosibelimab in cSCC," said James Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics. "Such PIP waivers enable us to proceed more quickly and cost-effectively when advancing our marketing approval applications with the EMA and MHRA, avoiding the significant time and expense required to conduct a pediatric clinical study in Europe. As such, these PIP waivers enhance the value of the cosibelimab program in Europe for Checkpoint and potential partners."
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