Video: CREON(R) (Pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New ...( - Therapy is medically-necessary for ...),Health

- Therapy is medically-necessary for thousands of patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions -

MARIETTA, Ga., May 1 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved CREON(R) (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. CREON(R) is the first and only pancreatic enzyme product (PEP) to receive FDA approval under new guidelines for the class.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/solvay/37345/

"Left untreated, EPI causes maldigestion, malabsorption and malnutrition and can ultimately be life-threatening," said Virginia Stallings, M.D., Director, Nutrition Center at the Children's Hospital of Philadelphia, PA and Professor of Pediatrics, University of Pennsylvania School of Medicine. "The goals of treating EPI are to optimize digestion and absorption of food and nutrients, improve outcomes for patients and prevent malnutrition and growth faltering in children and weight loss in adults. Pancreatic enzymes serve as an important component in the effective management of EPI throughout a patient's lifetime."

The efficacy of FDA-approved CREON(R) was demonstrated in a randomized, double-blind, placebo-controlled crossover study which enrolled 32 patients with CF. The primary efficacy endpoint was the coefficient of fat absorption (CFA), which measures the percentage of fat absorption relative to dietary fat intake. CREON(R) produced significantly greater mean CFA values compared to placebo in this study. The mean CFA during treatment with CREON(R) was 89% versus 49% during treatment wi
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