SecreFlo regulatory update

Repligen said it expects FDA to issue a complete response letter for SecreFlo to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. The company expects the agency to request additional clinical data, but said it does not know whether the agency will require another Phase III trial. Repligen also said FDA cancelled a May 31 meeting of the Gastrointestinal Drugs Advisory Committee to discuss the NDA for SecreFlo. Details were not disclosed. The synthetic human secretin is under Priority Review with a June 21 PDUFA date. The NDA is based on data from a re-read of MRI images from a Phase III trial showing that SecreFlo in combination with MRI significantly improved sensitivity of detecting pancreatic ducts' structural abnormalities compared to MRI alone with minimal loss in specificity by 2 out of 3 blinded radiologists. Repligen had reported that SecreFlo missed the co-primary endpoints of sensitivity and specificity but conducted the re-read after "numerous deficiencies" with the analysis of trial images conducted by the CRO overseeing the original analysis (see BioCentury, March 21, 2011). FDA and EMA agreed to the re-read in 2010 (see BioCentury, May 31, 2010). ...