FDA Issues Complete Response Letter to NDA for RG1068
Repligen announced that it has received a Complete Response Letter (CRL) FDA regarding the New Drug Application (NDA) for RG1068 (synthetic human secretin) for the improved detection of pancreatic duct abnormalities in patients with pancreatitis.
RG1068 was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with known or suspected pancreatitis. The CRL indicates that the FDA has completed its review of the RG1068 NDA and has determined that additional clinical efficacy and safety trial data will be required to support potential approval of the NDA. There were no specific safety concerns cited in the CRL, although safety will continue to be monitored in conjunction with any future clinical trial. No deficiencies were cited in the CRL with respect to the manufacturing, pharmacology or toxicology sections of the NDA.
RG1068 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. When used in combination with MRI, it stimulates the release of watery fluid into the pancreatic ducts “on demand” in order to improve MRI quality and more confidently identify pancreatic duct abnormalities. Such identification is important in determining the cause and potential treatment options for diseases such as pancreatitis.
For more information call (800) 622-2259 or visit www.repligen.com.