The Food and Drug Administration has approved two formulations of pancrelipase for different indications and patient populations, the agency announced on March 1.
A delayed-release capsule formulation of pancrelipase, which will be marketed as Ultresa, has been approved for treating for the treatment of exocrine pancreatic insufficiency caused by cystic fibrosis or other conditions in children and adults. The second pancrelipase formulation, which will be marketed as Viokace, has been approved in combination with a proton pump inhibitor for the treatment of exocrine pancreatic insufficiency from chronic pancreatitis or pancreatectomy in adults. The safety and efficacy of Viokace in children has not been established, according to the March 1 FDA statement announcing the approval.
Both products are a combination of porcine-derived lipases, proteases, and amylases.
The approval of these two products, along with three other pancreatic enzyme products that have been approved since 2009, "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," Dr. Julie Beitz, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research, said in the statement.
Since April 2010, manufacturers have not been allowed to manufacture and distribute unapproved pancreatic enzyme products. For years, they had been marketed in the United States as unapproved products, but because of problems with consistency in the amount of the enzymes contained in these products, the FDA required that these products had to go through the regular approval process before they were marketed.
The other pancreatic enzyme products (PEPs) – which contain the active ingredient pancrelipase, a mixture of the digestive enzymes amylase, lipase, and protease – that have been approved and meet FDA standards for safety, efficacy, and product quality" are Creon and Zenpep (2009), and Pancreaze (2010), the statement said.
Ultresa and Viokace are marketed by Aptalis Pharma U.S. Inc.