Omrix announced today that it has received a positive opinion for
EVICEL(TM) Fibrin Sealant (Human) from the Committee for Medicinal Products for Human Use (CHMP). Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery.
CHMP is the scientific committee of the European Medicines Agency (EMEA) and is responsible for reviewing medicinal product applications for quality, safety and efficacy. The CHMP's positive opinion for Evicel will now be forwarded to the European Commission for marketing authorization, which is expected by the end of the third quarter of 2008 (3Q08). The CHMP's opinion also stated that the approved indication for EVICEL would read as follows,
"Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery."
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a general hemostasis in surgery indication.
Upon its anticipated approval, EVICEL will be licensed for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix and ETHICON's supply and distribution agreement, ETHICON has the marketing rights for the EU.
About EVICEL:
Omrix say "We have been developing our next generation fibrin sealant, Evicel™, in collaboration with Ethicon. Evicel™ differs from Quixil® in that it does not contain an antifibrinolytic stabilizing agent in the Biologically Active Component. The presence of this agent resulted in Quixil® being contraindicated for surgical procedures involving direct contact with Cerebro Spinal Fluid and/or Dura Mater. "
EVICEL(TM) is an all-human, plasma-derived fibrin sealant currently indicated in the US as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. It does not contain aprotinin, which has been associated with adverse health effects. EVICEL(TM) is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing. On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.
The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.
“This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors
who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for the transmission of potentially contaminating bloodborne viruses. While the potential risk for infectious disease transmission is remote, it cannot be eliminated.
A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.
FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.
