Repligen Corporation, one of the leading supplier of critical biological products used to manufacture biologic drugs, 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 III 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.

“I would like to express my deep appreciation to our employees, clinical investigators and consultants for their dedication and hard work to accomplish this pivotal milestone for the company,” stated Walter C Herlihy, president and CEO of Repligen Corporation. “SecreFlo has the potential to be an important diagnostic tool to help radiologists and gastroenterologists confidently plan the best course of treatment for their patients.”

“We are very pleased to have filed Repligen’s first NDA and we look forward to continuing to work closely with the FDA to advance SecreFlo through the review process,” stated Dr Michael L Hall, chief medical officer at Repligen Corporation. “We currently expect to hear back from the FDA in 60 days if our application is accepted for review and whether FDA will grant the NDA priority review.”

SecreFlo has previously been granted Fast Track Designation based on the need to develop safer, non-invasive alternatives to diagnostic ERCP, an invasive endoscopic procedure used to diagnose and treat diseases of the pancreas which is potentially harmful for patients. The product has also been granted Orphan Drug Designation which qualifies Repligen to receive seven years of marketing exclusivity in the United States if we are the first company to obtain approval for SecreFlo in combination with MRI. There are more than 300,000 MRI procedures conducted in the US and Europe each year that could directly benefit from the addition of SecreFlo. We plan to file a Marketing Authorization Application in Europe next quarter.

SecreFlo, a synthetic version of the hormone secretin, stimulates secretion of watery fluid into the pancreatic ducts. When the pancreatic ducts are filled with water they are more effectively visualized by MRI. The pivotal phase III study was a multi-centre, baseline controlled, single dose study in which 258 patients enrolled at 23 clinical sites within the US and Canada received an MRI of the pancreas with and without SecreFlo, and separately an ERCP. The MRI images were randomized and independently reviewed by three radiologists for evaluation of the presence or absence of 10 pre-specified pancreatic duct abnormalities, image quality, visualization of the main pancreatic duct and confidence in diagnostic findings. The analysis of the phase III radiographic images was a “re-read” which was agreed to by the Food and Drug Administration and European Medicines Agency based on the determination that the original analysis was flawed and therefore inconclusive.