Repligen Corporation (RGEN) Announces Submission of Marketing Authorization Application in EU for SecreFlo™ to Improve Pancreatic Imaging in Patients with Pancreatitis
3/5/2012 6:37:08 AM
WALTHAM, Mass.--(BUSINESS WIRE)--Repligen Corporation (NASDAQ:RGEN) announced today that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for SecreFlo™ to improve detection of pancreatic duct abnormalities in patients with pancreatitis. SecreFlo™ (synthetic human secretin) is used in combination with magnetic resonance imaging (MRI) and is the Company’s lead diagnostic imaging product candidate. The MAA submission for SecreFlo™ follows on the recent grant of Priority Review by the U.S. Food and Drug Administration (FDA) for the Company’s new drug application (NDA) for SecreFlo™ in the same indication. Both the MAA and NDA filings are based on positive outcomes from the Company’s Phase 3 clinical trial results.