FDA Advisory Committee to review Repligen's SecreFlo NDA on May 31

Mar 26 2012

Repligen Corporation (NASDAQ:RGEN) today announced that the U.S. Food and Drug Administration's Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the Company's New Drug Application (NDA) for SecreFlo™ for the improved detection of pancreatic duct abnormalities in combination with magnetic resonance imaging (MRI) in patients with pancreatitis. Publicly available briefing documents for the meeting are expected to be posted to the FDA website two business days in advance of the Committee meeting.    

The SecreFlo™ NDA was submitted on December 21, 2011 and was granted Priority Review by the FDA with a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2012. Priority Review designation is given to product candidates that offer a significant improvement in the treatment, diagnosis or prevention of a disease or that address an unmet medical need.

Walter C. Herlihy, President and Chief Executive Officer of Repligen, said, "The Advisory Committee assigned to review the SecreFlo™ NDA will include relevant experts in the field of gastroenterology. The Committee meeting and our preparations for it provide an excellent opportunity to engage with a broader network of thought leaders as we near the potential FDA approval of SecreFlo™."

Source: Repligen Corporation