WALTHAM, Mass.--(BUSINESS WIRE)--Repligen Corporation (NASDAQ: RGEN) announced today that it has submitted a New Drug Application (NDA) for SecreFlo™ (RG1068, synthetic human secretin) to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. Structural abnormalities of the pancreatic ducts are a common cause of pancreatitis and may result in significant abdominal pain. In the pivotal Phase 3 study, the addition of SecreFlo™ to an MRI led to highly statistically significant improvements in sensitivity, image quality, ability to visualize the full length of the pancreatic ducts and diagnostic confidence when compared to MRI alone. A radiologist’s ability to more confidently identify the presence or absence of pancreatic duct abnormalities has the potential to improve patient triage and care. The SecreFlo™ NDA was filed with a request for priority review of the application which, if granted, would result in a 6 month review period.
