FDA grants Priority Evaluation for Repligen's SecreFlo NDA

Repligen Corporation declared that the U.S. Food and Drug Administration (FDA) has acknowledged for submitting and approved Priority Review towards the Company's new medicine application (NDA) for SecreFlo™ for better discovery of pancreatic duct disorders in affected individuals with pancreatitis.

With the help of PDUFA (Prescription Drug User Fee Act), the FDA's desire for finishing a Priority Review and presenting a choice on marketing consent is decreased to six months, when compared with ten months for the standard Review. The FDA has allotted a PDUFA goal date of June 21, 2012 to the SecreFlo™ NDA.

Priority Review designation is allocated to product aspirants that provide a considerable development throughout treatment, diagnosis or protection against a disease or that in fact address an unmet medicinal need. Priority Review for the SecreFlo™ NDA is based on the FDA's detection of a typical requirement for less risky, noninvasive choices to the diagnostic utilization of endoscopic retrograde cholangiopancreatography (ERCP). ERCP is definitely a persistent endoscopic system that has traditionally been utilized to analyze and evaluate conditions of the pancreas.

Magnetic resonance imaging (MRI) gives a less dangerous and noninvasive substitute for diagnostic ERCP; however, its value is currently restricted from the lack of an accepted source to boost MRI images of a typical pancreatic ducts with the intention to reach a certain diagnosis.

SecreFlo™, a synthetic version of our hormone secreting, when utilized in combination along with MRI, may fill this particularly unmet need. You will find approximately 300,000 abdominal MRI guidelines performed throughout U.S. and Europe every year that could directly take pleasure in the improvement of SecreFlo™.