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news.Eurand has completed the filing of its new drug application with the FDA for Zentase, the company's lead product candidate for the treatment of exocrine pancreatic insufficiency.
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In the new drug application (NDA), the company included results from two Phase III trials, one pivotal trial, and a supportive trial of Zentase in pediatric patients. Also included in the NDA were results from a gastrointestinal bioavailability study of Zentase conducted in chronic pancreatitis patients in the US, which was completed in November 2007.
Eurand initiated its rolling NDA submission in June 2007 and was granted fast-track designation by the FDA. Zentase is a porcine-derived pancreatic enzyme replacement therapy which is being developed to treat exocrine pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other conditions.
Gearoid Faherty, CEO of Eurand, said: “With the file now under review, our current focus is on the build out of our sales and marketing infrastructure for the anticipated launch of Zentase and integrating the recently announced SourceCF acquisition.”