Liprotamase regulatory update

FDA issued a complete response letter for Eli Lilly's liprotamase to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, pancreatectomy or other conditions. The agency asked the company to conduct an additional trial prior to a resubmission of the application for the pancreatic enzyme product (PEP). In January, an FDA advisory committee voted 7-4, with 1 abstention, against recommending approval of liprotamase for the indication. The panel found liprotamase's efficacy benefit to be modest, particularly compared to marketed porcine-derived PEPs, and felt that more safety data should be gathered prior to approval (see BioCentury, Jan. 17). ...