Yesterday, Repligen Corp. announced that the U.S. FDA has accepted for filing and granted Priority Review to the company's new drug application (NDA) for their product SecreFlo. The drug will be used to detect pancreatic duct abnormalities in patients with pancreatitis.
Based in Waltham, MA, Repligen is primarily focused on supplying products that aid in the manufacture of biologic drugs, and is using the accumulated expertise in this field to bring their SecreFlow product to market. The company also has two central nervous system rare disease programs in Phase 1 clinical trials. SecreFlow is a synthetic version of the naturally occurring human hormone secretin, produced in the small intestine and necessary during the human digestive process. SecreFlow can be used in patients to improve MRI quality when examining the pancreas.
SecreFlow is being developed as an alternative method of examining the pancreas, as opposed to endoscopic retrograde cholangiopancreatography (ERCP), an invasive procedure that has documented mortality risks. By granting SecreFlow priority review, the FDA will reduce the time it takes to deliver a decision on marketing approval from ten months to six months. This is in response to the recognized need for a safer alternative to ERCP. Repligen estimates that approximately 300,000 abdominal MRI procedures conducted in the U.S. and Europe each year may benefit from the use of SecreFlo.
Walter C. Herlihy, Ph.D., president and CEO of Repligen, said, "The commitment made by the FDA to expedite the review of the SecreFlo NDA underscores the need for safer, noninvasive methods for physicians to evaluate their patients with pancreatitis. If approved, we believe SecreFlo has the potential to improve pancreatic imaging and reduce the need for diagnostic endoscopy, to the benefit of patients and payers."
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