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™.”
Clinical Basis for SecreFlo™ NDA
The SecreFlo™ NDA was submitted to the FDA based on positive outcomes from the re-read of the Company’s Phase 3 clinical study. This pivotal study was a multi-center, baseline controlled, single dose study in which 258 patients were enrolled at 23 clinical sites in the U.S. and Canada. Each patient in the study received an MRI of the pancreas with and without SecreFlo™ and separately underwent endoscopy as a diagnostic reference. The MRI images were randomized and independently read and reviewed by three central radiologists.
The Phase 3 study’s co-primary endpoints were achievement of a statistically significant improvement in sensitivity with minimal loss in specificity. The study met its primary endpoints, demonstrating that the addition of SecreFlo™ to MRI resulted in a highly statistically significant improvement (p<0.0001) in sensitivity of detection of ten prespecified abnormalities of the pancreatic ducts, with minimal loss in specificity (<7.5%). All three secondary endpoints were also met, demonstrating highly statistically significant improvements (p<0.0001) in image quality, visualization of the main pancreatic duct and diagnostic confidence when compared to MRI alone. In addition, SecreFlo™ was shown to be safe and well tolerated. A radiologist’s ability to safely and more confidently identify and characterize pancreatic duct abnormalities has the potential to substantially improve “next-step” clinical decisions (patient triage) and patient outcomes.