FDA panel rebuffs Solpura

FDA's Gastrointestinal Drugs Advisory Committee voted 7-4, with one abstention, against recommending approval of Solpura liprotamase from Eli Lilly and Co. (NYSE:LLY) to treat exocrine pancreatic insufficiency (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 pancreatic enzyme products (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. ...