Repligen SecreFlo sNDA approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Repligen gains approval Nov. 1 to expand indications for SecreFlo (secretin) to include stimulation of pancreatic secretions to facilitate identification and cannulation of pancreatic ducts in patients undergoing endoscopic retrograde cholangio-pancreatography (ERCP). A randomized, placebo controlled crossover study in 31 patients undergoing ERCP resulted in 25 of 28 successful cannulations of the minor duct for SecreFlo compared to 1 of 16 for placebo, labeling notes. SecreFlo previously was approved for stimulation of pancreatic secretions to aid in the diagnosis of pancreatic exocrine dysfunction and for stimulation of gastrin secretion to aid in the diagnosis of gastrinom
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