Seprafilm Cleared For Widespread Use In USA

Genzyme's Seprafilm, a hyaluronic acid-based bioresorbable membrane to prevent adhesions in patients undergoing major surgery, has been approved by the US Food and Drug Administration for a much broader indication than many industry observers had expected.

The FDA has approved Seprafilm for "use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder and stomach and between the uterus and surrounding structures such as tubes and ovaries, large bowel and bladder."

Back in March, an FDA advisory panel recommended that the product should be approved, but with the caveat that the target population should be restricted to those enrolled into the clinical trials of the product used to support the premarket approval (PMA) application (Marketletter April 1). At the time, some analysts took this to mean that Seprafilm would only be approved for use in colectomy and myomectomy, which would have drastically limited the potential sales of the product.