Solpura liprotamase regulatory update

FDA's Gastrointestinal Drugs Advisory Committee voted 7-4, with 1 abstention, against recommending approval of Eli Lilly's Solpura liprotamase 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 3 types of microbially derived pancreatic enzymes and would be the first PEP not to be derived from pigs if approved. ...