Abbott’s Creon Granted Approval For Supplemental New Drug Application - Update

Broad-based health care company Abbott Laboratories (ABT) announced Monday that the U.S. Food and Drug Administration approved its supplemental New Drug Application or sNDA for Creon to include dosing guidance in the prescribing information specific to patients with exocrine pancreatic insufficiency or EPI, a condition of limited production of pancreatic enzymes due to chronic pancreatitis or removal of the pancreas. Prior to this FDA approval, dosing guidance for medications such as Creon was based on patients with cystic fibrosis.

Creon (pancrelipase) delayed-release capsules now include dosing guidance in the prescribing information specific to patients with EPI due to CP or chronic pancreatitis or a pancreatectomy.

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 develop EPI.

This insufficiency reduces the production or secretion of enzymes that are necessary to digest fats, proteins and carbohydrates in food and can result in a type of oily diarrhea known as steatorrhea, malabsorption of nutrients, weight loss, bloating, abdominal pain and even chronic malnutrition if left untreated.

EPI can occur as a complication of a variety of diseases or conditions, such as cystic fibrosis, chronic pancreatitis, pancreatic cancer and gastrointestinal surgery.

Pancrelipase is a form of enzyme therapy for the treatment of various digestive disorders. It is a mixture of three digestive enzymes, amylase, protease, and lipase, which are normally produced by the pancreas.

Abbott in its statement said the approval makes Creon the first medication in its class to have guidance and information for use in treating EPI due to CP and pancreatectomy.

Creon’s sNDA approval was based on results of a double-blind, randomized, placebo-controlled, two-arm, parallel-group study, enrolling 54 adults with EPI due to CP or pancreatectomy. The primary efficacy endpoint was to measure the amount of fat absorbed by the patient’s body rather than excreted.

In April 2009, Creon was approved as a Pancreatic Enzyme Replacement Therapy or PERT by the FDA. PERTs work in patients with EPI by delivering pancreatic enzymes to the small intestine to help break down fats, proteins and carbohydrates in food, thereby acting as a replacement for digestive enzymes physiologically secreted by the pancreas.

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

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