Repligen announced that the U.S. Food and Drug Administration (FDA) will give priority review to the company's new drug application (NDA) for SecreFlo in combination with MRI to improve the detection of pancreatic duct abnormalities in patients with pancreatitis.
SecreFlo is a synthetic version of the natural human hormone secretin, which is produced in the small intestine and is important to the process of digestion. It would be used with MRI as a noninvasive alternative to endoscopic retrograde cholangiopancreatography (ERCP), an invasive endoscopic procedure to examine and evaluate diseases of the pancreas.
The SecreFlo NDA was submitted to the FDA based on a phase III study in which 258 patients were enrolled at 23 clinical sites in the U.S. and Canada. Each participant received an MRI scan of the pancreas with and without SecreFlo and separately underwent ERCP as a diagnostic reference.
According to Repligen, the study showed that SecreFlo and MRI produced statistically significant improvement in the sensitivity of detection of pancreatic duct abnormalities with minimal loss in specificity, as evaluated by two of three radiologists reading the MRI results.
Under the Prescription Drug User Fee Act, the FDA's goal is to complete a priority review and make a decision on marketing approval in six months.
