Ethicon submits BLA to FDA for Fibrin Pad

Ethicon, Inc., a worldwide leader in surgical care, announced today that the company has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery.

"Excessive bleeding during surgical procedures is a serious and challenging problem. Currently available treatment options in these settings are not always satisfactory and so surgeons are looking for a safe and effective alternative," said Dan Wildman, Worldwide President with responsibility for the Ethicon Biosurgery Business. "Our development of this product candidate is aimed at meeting this significant unmet need."

The Fibrin Pad is intended for use by surgeons as an adjunct to hemostasis when surgical methods are ineffective or impractical to control bleeding. Its novel design combines two methods of action (the mechanical mechanism of the device coupled with the biologic mechanism of the two biologics).

"The Fibrin Pad product candidate is an excellent example of convergence within Johnson & Johnson, bringing together our medical device and pharmaceutical expertise to bring true innovation to the market," said Dr. Jim Hart, Vice President Medical Affairs, Ethicon, Inc. "The results observed in the clinical trial are very encouraging. This clinical trial is just the first chapter in a stepwise clinical development plan that is ongoing and is intended to evaluate the product candidate in a variety of tissue types and in increasing intensities of bleeding."

The BLA submission includes efficacy and safety data from a randomized, controlled clinical study, in which the Fibrin Pad was used as an adjunct to hemostasis in soft tissue bleeding. The proposed indication is: as an adjunct to hemostasis for soft tissue bleeding during retroperitoneal, intra-abdominal, pelvic, and (non cardiac) thoracic surgery when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.