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Ethicon BLA for surgical drug-device combo

Johnson & Johnson's Ethicon subsidiary has submitted a Biologic License Application to the US FDA for a device that also contains prescription drugs
Reflecting a growing trend toward the development and marketing of devices that also contain prescription drugs, Johnson & Johnson's (J&J) Ethicon subsidiary has submitted a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for the Fibrin Pad, which combines biomaterials and the plasma-derived biologics Human Fibrinogen and Human Thrombin to reduce bleeding during surgery.

The submission "is an excellent example of convergence within Johnson & Johnson, bringing together our medical device and pharmaceutical expertise," said Dr Jim Hart, vice president medical affairs, Ethicon.

The pad is intended for use as an adjunct to homeostasis when surgical methods for controlling bleeding are ineffective or impractical. Specifically, the BLA seeks clearance for use of the pad during retroperitoneal, intra-abdominal, pelvic, and (non cardiac) thoracic surgery.

The marketing application centres around data from a randomised, controlled clinical study that tested the Fibrin Pad as an adjunct to hemostasis in soft tissue bleeding.

Ethicon licensed the fibrin sealant biologicals used in the product from Omrix Biopharmaceuticals, a company focused on biosurgical and passive immunotherapy products.

Omrix has estimated that there is a potential $400m global market opportunity for the Fibrin Pad. 

22nd November 2010

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