U.S. Food and Drug Administration (FDA) has approved Eurand’s New Drug Application (NDA) for ZENPEP(TM) (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.
ZENPEP is the only FDA-approved pancreatic enzyme product (PEP) that has been evaluated in clinical studies in adults and children — including children from one to 12 years old — and will offer four dosage strengths to meet the varied needs of infants, toddlers, adolescents and adults with EPI.
“The availability of clinical evidence in a pediatric population is particularly important for EPI patients with CF and their caregivers, as early improvements in BMI (Body Mass Index) significantly affect long-term survivability,” said Jamie Wooldridge, M.D., Assistant Professor, Department of Pediatrics, Division of Pulmonary Medicine at Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, and a principal investigator in the ZENPEP pediatric trial.
ZENPEP capsules were formulated to allow the contents to be sprinkled on food where necessary, which is a key attribute to support the developmental needs of very young children as well as older patients.
EPI is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. Loss of digestive enzymes leads to maldigestion and malabsorption of nutrients. This 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. EPI results in malnutrition and, especially in CF patients, impaired growth in children, compromised immune response and shortened life expectancy.
ZENPEP replaces these missing enzymes and improves digestion and absorption. In addition, ZENPEP’s stability and precise range of dosage strengths will allow health care professionals to dose a patient’s treatment regimen for optimal symptom control and potentially reduce their pill burden.
ZENPEP was developed specifically to meet the FDA’s guidelines on PEPs. Historically, PEPs have not been regulated and approved by the FDA. In 2004, due to inconsistent quality that affected the safety and efficacy of PEPs, the FDA determined it was necessary to better control these products. All manufacturers of EPI drug products were required to file NDAs and receive marketing approvals by April 2010.
“For years, patients with EPI taking unapproved PEPs have lived with far too much variability in the control of their gastrointestinal symptoms as a result of product instability and dosing inconsistency,” said Gearoid Faherty, Chairman and Chief Executive Officer. “The approval of ZENPEP is a major milestone for patients suffering from EPI and for Eurand (NASDAQ: EURX). In preparation for our U.S. launch we have built and continue to expand a first-rate commercial organization to help ZENPEP reach its full market potential.” According to IMS Health, the market for PEPs was an estimated $1.13 billion worldwide in 2008.
The U.S. commercial launch of ZENPEP is planned for the fourth quarter of 2009. Eurand will market ZENPEP for the approved indication through its own sales force to the different physician groups that treat EPI within each of the target CF and non-CF patient populations.
Source: Eurand, USA