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March 2010

New and Improved Pancreatic Enzymes - March 2010 - Connections - Cystic Fibrosis Foundation

New and Improved Pancreatic Enzymes

Although pancreatic enzyme therapies have been around for decades, they are now undergoing a more rigorous review to help ensure that people with cystic fibrosis receive only the best and most effective enzyme treatments.

New FDA Requirements

In 2004, the U.S. Food and Drug Administration (FDA) required that all pancreatic enzyme replacement therapies currently on the market be reformulated and undergo clinical testing in order to receive FDA approval.

More than 90 percent of people with cystic fibrosis take pancreatic enzyme replacements to help the body absorb essential vitamins and nutrients.

“I rely on enzymes every day to stay healthy, and it makes me feel better knowing the FDA has taken this step,” says Nicole Ellis, an adult with CF.

The CF Foundation urged the FDA decision, which will help ensure that CF patients receive only pancreatic enzyme products that are documented to be both safe and effective.

In CF, thick, sticky mucus builds up in the pancreas, preventing the release of important enzymes that aid in digestion. This build-up can lead to malnutrition. Pancreatic enzymes combat this problem.

Recently Approved Enzymes

The first pancreatic enzyme replacement therapy to be evaluated and approved under this new mandate was CREON® by Solvay Pharmaceuticals, Inc. CREON received approval in May of 2009.

In September 2009, Eurand N.V. announced that the FDA approved its enzyme product, ZENPEP™ — the second enzyme therapy to be granted FDA approval.

In addition, Alnara Pharmaceuticals, Inc. is completing a Phase 3 long-term safety study of an enzyme called liprotamase. Following completion of the study, Alnara will carry out clinical and regulatory activities needed for FDA approval.

Other companies completing clinical trials for pancreatic enzyme products include Axcan Scandipharm (Ultrase®), DCI (PANCRECARB®) and Johnson & Johnson (PancreazeTM).

“The CF Foundation is pleased that a growing number of FDA-approved pancreatic enzymes are now becoming available to patients,” said Preston W. Campbell, III, M.D., executive vice president for medical affairs of the CF Foundation. “FDA review is an important step to ensure that people with CF are getting the maximum benefit from their pancreatic enzymes.”

Because there is a connection between better lung function and higher body weight, pancreatic enzymes are a vital part of CF care. It is important for people with CF to take pancreatic enzymes with all meals and snacks.

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