Pancreatic enzyme-replacement therapy in CF: considerations for the USA

Pancreatic enzyme products (PEPs) have been commercially available since before the passage of the Food, Drug and Cosmetic Act in 1938. They are a vital therapy for patients with cystic fibrosis and exocrine pancreatic insufficiency. PEPs help to enhance absorption of nutrients and thereby play an important role in maintaining good nutritional status and preserving lung function. The benefits of these supplements are not limited to cystic fibrosis and also extend to patients with other conditions, such as chronic pancreatitis. Concerns over the safety and consistency of PEPs have led to the requirement that all PEPs be approved by the US FDA. Clinical studies are currently underway to demonstrate the safety and efficacy of different PEPs, including new formulations that meet FDA guidelines for no enzyme overfill. This review highlights currently available PEPs and new formulations that hold promise for patients with exocrine pancreatic insufficiency.