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FDA asks for additional Solpura trial

April 18, 2011 11:59 PM UTC

FDA asked Eli Lilly and Co. (NYSE:LLY) to conduct an additional clinical trial prior to approval of exocrine pancreatic insufficiency (EPI) candidate Solpura liprotamase. The request came in a complete response letter for an NDA for the pancreatic enzyme product (PEP). In January, an FDA advisory committee voted against recommending approval of Solpura to treat EPI due to cystic fibrosis (CF), chronic pancreatitis, pancreatectomy or other conditions. The panel found Solpura'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. Solpura is a combination of three types of microbially derived pancreatic enzymes and would be the first PEP not to be derived from pigs if approved (see BioCentury, Jan. 24). ...