Eurand has received FDA approval of its New Drug Application (NDA) for ZENPEP (pancrelipase) delayed-release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.The US launch of ZENPEP is planned for the fourth quarter of 2009.
ZENPEP was shown to be safe and effective for 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). Both the studies has established efficacy and safety of ZENPEP in CF patients with EPI.
In the placebo-controlled, randomized, double-blind pivotal study in older children and adult patients, ages 7-23 years, the primary efficacy endpoint was mean Co-efficient of Fat Absorption (CFA). CFA was statistically higher with ZENPEP treatment (88.3%) than placebo (62.8%).
In the open-label, single-arm study in young patients, patients maintained symptom control when switched from their usual PEP regimen to ZENPEP at similar doses. The safety and efficacy in pediatric patients evaluated in this study were similar to adult patients.
Gearoid Faherty, chairman and CEO of Eurand, said: The approval of ZENPEP is a major milestone for patients suffering from EPI and for Eurand. In preparation for our US launch we have built and continue to expand a first-rate commercial organization to help ZENPEP reach its full market potential.
Eurand is committed to a successful launch of ZENPEP and intends to deploy a sales force of sufficient size and scope to address these distinct market segments. To accelerate adoption, we will also have an extensive sampling and patient support program for a period of time following the launch.