Zentase NDA Granted Priority Review

The FDA is giving Zentase, a pancreatic enzyme replacement therapy, priority review with a decision likely in June.

Eurand, which makes Zentase (pancrelipase capsules), completed its rolling new drug application (NDA) submission last December. It initiated the submission in June 2007 and was granted fast-track designation by the FDA for the treatment of exocrine pancreatic insufficiency.

Eurand CEO Gearóid Faherty said the company is focusing on the build-out of its U.S. specialty sales force in preparation for Zentase’s potential launch.

Zentase is a porcine-derived pancreatic enzyme replacement therapy being developed to treat pancreatic insufficiency, which is associated with cystic fibrosis, chronic pancreatitis and other conditions.