FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

May 3 2010

Abbott (NYSE: ABT) announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for CREON® (pancrelipase) Delayed-Release Capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy).  Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.  

Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas.  Patients with chronic pancreatitis or those who have had their pancreas removed (to manage conditions of the pancreas such as CP, pancreatic cancer or pancreatic tumors) often develop EPI. This insufficiency reduces the production or secretion of enzymes that are necessary to digest nutrients in food and can result in a type of oily diarrhea known as steatorrhea, malabsorption of nutrients, weight loss and even chronic malnutrition if left untreated.

With this FDA approval, CREON is the first medication in its class to have this guidance and information in its prescribing information for use in treating EPI due to CP and pancreatectomy.

"Without proper dosing guidance, some patients have previously attempted to control EPI symptoms by modifying their diets and limiting fat intake," said Orelle Jackson, executive director of the National Pancreas Foundation.  "However, this approach has yielded limited treatment success."

The sNDA approval was based on results of a double-blind, randomized, placebo-controlled, two-arm, parallel-group study which enrolled 54 adults with EPI due to CP or pancreatectomy.  The primary efficacy endpoint was a clinical measurement of how much fat consumed by a patient is absorbed by the body rather than excreted.

"Until now, patients who have had their pancreas removed or those with chronic pancreatitis have too often received inadequate doses of pancreatic enzymes to address their symptoms," said David C. Whitcomb, M.D., Ph.D., University of Pittsburgh Medical Center.  "The availability of new data for CREON is a benefit to prescribers by providing appropriate dosing information that can impact the treatment of these patients."