FDA Approves Two New Pancreatic Enzymes

Emma Hitt, PhD


March 01, 2012

March 1, 2012 — The US Food and Drug Administration (FDA) has approved 2 new pancreatic enzyme products to aid food digestion: pancrelipase delayed-release capsules (Ultresa, Aptalis Pharma) and pancrelipase tablets (Viokace, Aptalis Pharma).

Ultresa is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF) or other conditions. Viokace, in combination with a proton-pump inhibitor, is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.

"The approvals of Ultresa and Viokace, along with the other approved pancreatic enzyme products, allow health care providers to prescribe the product that is most appropriate for the estimated 200,000 patients in the United States who have pancreatic insufficiency," said Julie Beitz, MD, the director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research.

Although many pancreatic enzyme products are available, the FDA established that makers of these products should stop manufacturing and distributing unapproved products by April 28, 2010.

The two new products add to 3 approved pancreatic enzyme products: Creon (Abbott Laboratories), Zenpep (Aptalis), and Pancreaze (Janssen Pharmaceuticals, Inc).

At an FDA Pediatric Advisory Committee Meeting held January 30, 2012, the 3 forms of pancrelipase were recommended for return to routine monitoring during an abbreviated review that indicated no new safety signals in pediatric patients.

A manufacturer press release states that the 2 newly approved products will be launched in the United States in the near future.

The most common (>7%) adverse reactions in patients treated with Ultresa were headache, pharyngolaryngeal pain, and epistaxis, whereas with Viokace, the most common effects were biliary tract stones and anal pruritus.

The manufacturer recommends that Ultresa should not be chewed or retained in the mouth to avoid irritation of oral mucosa. They add that caution should be exercised with use of Ultresa in patients with gout, renal impairment, or hyperuricemia. They also warn of a theoretical risk for viral transmission with all pancreatic enzyme products, including Ultresa and Viokace.

The FDA notes that pancreatic enzyme products (PEPs) are not approved for administration via gastrostomy tubes, but "a small number of patients may require PEPs to be given through this route. Manufacturers of approved PEPs are currently conducting tests to evaluate the feasibility of administering PEPs via gastrostomy tubes."

They also suggest to healthcare professionals that when switching a patient to another PEP, they should start with a similar amount of lipase enzyme, then adjust the dose according to the patient's response. They should also recognize that it may take 1 to 2 weeks for a patient to adjust the dose of the new PEP.

Individual patient response should be monitored when a patient is switched from an unapproved PEP to an approved one.


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