Eurand's NDA for Zentase was accepted and has been granted priority review by FDA. Gearoid Faherty, chief executive officer of Eurand, commented, "We are extremely pleased with the FDA decision to grant Zentase priority review. We understand that the typical FDA review period of a drug with priority review status is six months versus a standard 10-month review. In the interim, we remain focused on the build-out of our U.S. specialty sales force in preparation for the potential commercialization of Zentase.''
Zentase is a porcine-derived pancreatic enzyme replacement therapy being developed to treat pancreatic insufficiency, a condition associated with CF, chronic pancreatitis and other conditions. The product is a highly stable formulation that includes eight key enzymes, a number of coenzymes and cofactors, and is biologically similar to human pancreatic secretions necessary for proper human digestion. The company completed its rolling NDA submission in December 2007.
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