Zenpep Receives FDA Approval for Pancreatic Digestive Issues


Yesterday Eurand N.V. announced Zenpep (pancrelipase) Delayed Release Capsules have been given U.S. Food and Drug Administration (FDA) approval for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.

Zenpep is the first pancreatic enzyme product to have been evaluated in both adults and children (ages 1 to 12). It will available in four dosage strengths to meet the varied needs of infants, toddlers, adolescents and adults with EPI.

Zenpep was evaluated for safety and effectiveness in the treatment of EPI in two Phase III multicenter clinical trials -- one in older children, adolescents and adults, and one in young children (ages 1 through 6). Fat absorption was statistically higher with Zenpep treatment (88.3%) than placebo (62.8%).

Zenpep was not associated with any serious drug-related adverse events in any of the clinical trials. The most common adverse events were gastrointestinal complaints. The most commonly reported adverse events included: abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion. The type and incidence of adverse events were similar in children and adults.

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Patients with EPI lack digestive enzymes made by the pancreas. This result in the inability to digest their food properly, leading to maldigestion and malabsorption of nutrients. EPI is a common disorder for those suffering from cystic fibrosis and other conditions compromising the exocrine function of the pancreas, such as pancreatic cancer, gastrointestinal surgery and chronic pancreatitis.

"The availability of clinical evidence in a pediatric population is particularly important for EPI patients with cystic fibrosis and their caregivers, as early improvements in body mass index significantly affect long-term survivability," said Jamie Wooldridge, MD, Assistant Professor, Department of Pediatrics, Division of Pulmonary Medicine at Cincinnati Children's Hospital Medical Center, in a prepared statement.

Cystic fibrosis (CF) is a life-threatening genetic disease that affects approximately 30,000 children and adults in the United States and nearly 70,000 people worldwide. It causes life-threatening lung infections and serious digestive complications. CF is caused by a mutation in the CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene whose lack of proper function leads to the symptoms, complications and premature mortality in people with CF.

The Cystic Fibrosis Foundation is a great source for more information, visit www.cff.org.

Eurand News Release