FDA issues Complete Response Letter for RG 1068 (Repligen) for Pancreatic MRI Imaging

Repligen Corporation has announced that it has received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for RG1068 (synthetic human secretin). RG1068 was evaluated in a Phase III 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.