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 started the submission last June and was granted fast-track designation by the FDA for the treatment of exocrine pancreatic insufficiency (EPI).

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

Last April, the company released data from two Phase III clinical trials of the drug showing it could alleviate serious malabsorption associated with EPI in both pediatric and older patients.