FDA approves J&JPRD's PANCREAZE NDA

Apr 15 2010

Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for PANCREAZE™ (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.  Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas that are important in the digestion of fats, proteins, and sugars.

PANCREAZE is a combination of porcine-derived lipases, proteases, and amylases. Prior to FDA approval of PANCREAZE, PANCREASE MT has been available in the United States since the 1980's from McNeil Pediatrics, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.  The FDA approval is a result of J&JPRD's response to the 2004 FDA requirement that all pancreatic enzyme products be made available by prescription only and be approved through the new drug application process to standardize manufacturing procedures and enzyme activity  in pancreatic enzyme products. New clinical trials evaluating efficacy and safety in infants, children and adults with cystic fibrosis were performed by J&JPRD to support the approval for PANCREAZE.  In addition to complying with the requirements of the Federal Register notice, the product name was changed to conform to the FDA's current nomenclature guidance for new products.

"Certain medical conditions can decrease the amount of digestive enzymes that are normally produced by the pancreas. When the body does not have enough of these enzymes, it becomes more difficult to digest fats, proteins and sugars," said Bruce Trapnell, M.D., Francis R. Luther Professor of Medicine and Pediatrics, University of Cincinnati School of Medicine and principal investigator for one of the clinical trials on PANCREAZE. "I'm pleased the FDA has approved PANCREAZE, so that patients who are unable to produce enough pancreatic enzymes can now receive this prescription treatment."

Source: http://www.jnj.com/