Repligen has filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for its diagnostic imaging product candidate, SecreFlo.
SecreFlo (synthetic human secretin) is used to improve detection of pancreatic duct abnormalities in patients with pancreatitis and is used in combination with magnetic resonance imaging (MRI).
The MAA submission for SecreFlo was filed following the recent grant of Priority Review by the US Food and Drug Administration (FDA) for the company’s new drug application (NDA) for SecreFlo in the same indication.
Both the applications submissions are based on positive outcomes from the company’s Phase 3 clinical trial results.
The baseline, controlled, multi-center, pivotal and single dose study which enrolled 258 patients received an MRI of the pancreas with and without SecreFlo and separately underwent endoscopy as a diagnostic reference.
The study met its primary endpoints with improvement in sensitivity of detection of ten prespecified abnormalities of the pancreatic ducts, with minimal loss in specificity.
The study also met secondary endpoints with statistically significant improvements in image quality, visualization of the main pancreatic duct and diagnostic confidence when compared to MRI alone.
Repligen chief medical officer Michael Hall said the company is pleased to have filed the SecreFlo MAA and look forward to work closely with the European regulators to address any questions during the review process.
"We believe SecreFlo will become an important diagnostic tool to help radiologists and gastroenterologists confidently plan the best course of treatment for their patients with pancreatitis," Hall added.