Repligen (RGEN) Gets CRL from FDA for RG1068 NDA; Additional Data Needed
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Repligen Corporation (Nasdaq: RGEN) has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for RG1068 (synthetic human secretin). 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.
Repligen filed its NDA for RG1068 on December 21, 2011 based on the re-read of Phase 3 clinical trial data. On February 21, 2012, the FDA accepted the NDA filing and granted it priority review based on its prior Fast Track designation. In addition, on March 5, 2012, Repligen submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) that was successfully validated for full review by the EMA’s Committee for Medicinal Products for Human Use.
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Repligen filed its NDA for RG1068 on December 21, 2011 based on the re-read of Phase 3 clinical trial data. On February 21, 2012, the FDA accepted the NDA filing and granted it priority review based on its prior Fast Track designation. In addition, on March 5, 2012, Repligen submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) that was successfully validated for full review by the EMA’s Committee for Medicinal Products for Human Use.
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