Lisata Therapeutics receives PIP waiver from EMA for certepetide

Lisata Therapeutics announced that it has reached agreement with the European Medicines Agency, EMA, on a Paediatric Investigation Plan, PIP, for Lisata’s lead investigational product, certepetide, in pancreatic cancer. The EMA has agreed to a product-specific full pediatric waiver for certepetide in pancreatic cancer. The Paediatric Committee, PDCO, of the EMA recommended and the EMA granted a waiver for certepetide for all subsets of the pediatric population for the treatment of pancreatic cancer on the grounds that “pancreatic cancer occurs only in adults.” This waiver removes any requirement for Lisata to conduct clinical studies of certepetide in children in support of an overall marketing authorization application in Europe for pancreatic cancer. It also allows Lisata to focus its development efforts on bringing this therapy to relevant patients with pancreatic cancer as quickly as possible.