First FDA-approved pancrelipase product may mark new era for providers, patients

Abstract

FDA’s recent approval of a reformulated version of Solvay Pharmaceutical Inc.’s delayed-release pancrelipase product, Creon, gives pharmacists who are active in the cystic fibrosis community something new—a pancreatic enzyme product that has passed regulatory muster. Solvay expects the new Creon formulation to be available later this year. The product is indicated for the treatment of children and adults with exocrine pancreatic insufficiency caused by cystic fibrosis or other conditions. The delayed-release oral formulation is designed to release lipase, protease, and amylase in the small intestine instead of the acidic environment of the stomach, which degrades pancreatic enzymes, according to FDA. Only one other pancrelipase product has ever gained FDA approval—Organon’s Cotazym, an immediate-release pancrelipase product that was approved by FDA in 1996 but is not currently marketed, according to the agency. Pancreatic enzyme products have been available in the United States since before the 1938 passage of the Food, Drug, and Cosmetic Act. FDA in 2004 declared pancreatic enzyme products new drugs that required formal agency approval. The agency has given manufacturers until April 2010 to obtain marketing approval of their pancrelipase products.