Surgery News - March 2008 - (Page 18) 18 DRUG DEVELOPMENTS NEW INDICATIONS & APPROVALS SURGERY NEWS • M A R C H 2 0 0 8 Recothrom, Evicel Recothrom (ZymoGenetics Inc.) A topical recombinant human thrombin solution approved as an aid to hemostasis “whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical,” according to the Food and Drug Administration. Recommended Usage: Apply directly on the surface of bleeding tissue; can be used with an absorbable gelatin sponge. Special Considerations: For topical use only. Data on repeat exposure are limited, so ZymoGenetics has agreed to conduct a postmarketing study to evaluate the immunogenicity and safety of reexposure to Recothrom, according to the FDA. Comment: With this approval, “surgeons can choose recombinant thrombin, thrombin derived from human plasma, or thrombin derived from cattle plasma to help control bleeding and oozing,” Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA statement. In a double blind, randomized phase III pivotal study, Recothrom was compared with a commercially available bovine thrombin product in 401 patients aged 21-89 years who were undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access. Hemostasis at a prespecified bleeding site was achieved in 10 minutes or less (the primary efficacy end point) in 95% of both groups. The proportion of patients achieving hemostasis within 1.5, 3, and 6 minutes (secondary end points) was also comparable in both groups ( J. Am. Coll. Surg. 2007;205:256-65). Overall complications were similar between the two groups, and no adverse events were identified as being causally related to Recothrom, according to the package insert. Significantly fewer patients in the human thrombin group (1.5%) developed human thrombin antibodies, compared with patients in the bovine thrombin group who developed bovine thrombin antibodies (21.5%). The recombinant product “has none of the downsides of the existing thrombin products and appears to be extremely safe,” Dr. Fred Weaver, one of the study’s investigators, said in an interview. Because human thrombin is a purified, human analogue thrombin, it is less likely to be antigenic than bovine thrombin products. Compared with human thrombin derived from human plasma, it does not have the theoretical risk of viral transmission, and it can be produced in unlimited quantities, added Dr. Weaver, associate director of the University of Southern California Center for Vascular Care, Los Angeles. Dr. Weaver said he has served as a consultant to ZymoGenetics, which sponsored the studies. The wholesale acquisition cost for a vial containing 5,000 IU of Recothrom is $86, according to a company spokesperson. Evicel (Omrix Biopharmaceuticals Inc.) A fibrin sealant derived from human plasma approved for use as an adjunct to hemostasis during general surgery. Previously approved for the same indication in patients undergoing liver surgery (2003) or vascular surgery (2007). Recommended Usage: Sprayed or dripped onto the surface of bleeding tissue to form a thin, even layer that helps stop bleeding. Special Considerations: For topical use only. Should not be injected directly into the circulatory system or used for “severe or brisk” arterial bleeding; and as with all plasma-derived products, “the risk of transmitting infectious agents cannot be completely eliminated,” according to the manufacturer. Comment: Evicel, which is derived from the plasma of human donors, contains fibrinogen and thrombin, and was shown to be safe and effective in controlling bleeding in a study of 135 patients undergoing abdominal surgery, said the FDA. “This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” Dr. Goodman of the FDA said in a statement. Evicel, previously called Crosseal, has a unit price of $95/mL, according to the company. —Elizabeth Mechcatie American College of Surgeons 94th annual Clinical Congress October 12–16, 2008: San Francisco, CA Moscone Convention Center Save the Date! Join us in San Francisco for the 94th annual Clinical Congress. As always, it will be an educational opportunity you won’t want to miss! Please be sure to visit www.facs.org in the coming months for more details regarding the educational program, registration, housing, and transportation. http://www.facs.org
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