Thrombin (Human) - Evithrom
Status: recently approved in U.S.
Organizations involved:
Omrix Biopharmaceuticals – Manuf.; R&D; Tech.; Former
Ethicon, Inc. – R&D; Tech.; World mark.
Johnson & Johnson – World mark.; Parent
Baxter Healthcare - Patent dispute
Cross ref.: See the Thrombin Products entry (#919), and the entry for Evicel/Quixel, a fibrin sealant from Omrix (#736) containing human thrombin (this product) as a component.
Description: Omrix is developing human Plasma-derived stabilized thrombin formulated with calcium chloride as a stand-alone product. Unlike the current commercial bovine thrombin (Thrombin-JMI), no material of animal origin is present in this product, and products derived from human plasma are likely to be less immunogenic than products derived from animal sources (with Thrombin-JMI having a black box warning about this).
Ethicon/J&J markets Evithrom as both a stand-alone thrombin and with absorbable gelatin sponges, e.g., SurgiFlo Hemostatic Matrix. Evithrom is shipped frozen and can be stored in the freezer for up to two years. Unlike Thrombin-JMI, Evithrom does not need to be reconstituted with a needle before use.
Nomenclature: Thrombin/Omrix [BIO]; Evitrhom [TR]; Thrombin, Topical (Human) [FDA]; Thrombin (Human) [SY]
Companies.: Evithrom was jointly developed by Omrix Johnson & Johnson Wound Management, a division of Ethicon, Inc. holds marketing rights.; and is manufactured by Omrix in Kiryat Ono, Israel, CBER/FDA est. no. 1603.
In Nov. 2008, Johnson & Johnson fully acquired OMRIX, with world marketing by its Ethicon subsidiary.
Approvals: Date = 20070827; BLA
Indications: [full text of the "Indications: and Usage" section of the product insert/labeling]:
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.
May be used in conjunction with an Absorbable Gelatin Sponge, USP (
Status: On Nov. 6, 2006, Omrix filed a BLA for FDA approval of its topical human thrombin as a stand-alone product with a general hemostasis. The BLA filing was based on a multi-specialty, pivotal Phase III trial which measured and demonstrated the equivalence of topical human thrombin to bovine thrombin (Thrombin-JMI) in achieving hemostasis in general surgery procedures in terms of safety and efficacy.
In its BLA, the FDA allowed Omrix to cross reference the Chemistry, Manufacturing and Controls (CMC) and preclinical sections of its Evicel file. Evicel is the company’s currently U.S. licensed and marketed fibrin sealant (see entry #736).
Evithrom is the first human thrombin approved in the U.S. since 1954, and is the only one currently approved
Tech. transfer: In 2014, Baxter International filed suit alleging that Johnson & Johnson’s SurgiFlo, e.g., FloSeal, family of products violate six patents relating to Baxter’s Floseal hemostatic matrix. In addition to J&J, the complaint named J&J’s Ethicon division, Ferrosan Medical Devices A/S and Packaging Coordinators, Inc.
Trials: In Oct. 2006, Omrix reported positive results from its Phase II pivotal clinical trial of human thrombin in hemostasis in general surgery procedures. This non-inferiority clinical trial evaluated the equivalence of topical human thrombin to bovine thrombin (Thrombin-JMI) in terms of safety and efficacy. All primary endpoints were met.
In clinical trials, one patient who received human throm-bin was antibody-positive or formed antibodies to the product. The antibody value for this patient was just below the preset criteria for positive response. In contrast, seventeen patients who received bovine thrombin developed antibodies to bovine coagulation proteins using similar preset criteria.
Ongoing: Prior to its acquisition, Omrix was developing a Fibrin Patch for marketing by Ethicon Inc., a Johnson & Johnson company.
Companies involvement:
Full monograph
809 Thrombin/Omrix
Nomenclature:
Thrombin/Omrix [BIO]
Evithrom [TR]
Thrombin, Topical (Human) [FDA]
Thrombin (Human) [SY]
FDA Class: Biologics BLA
Year of approval (FDA) = 2007
Date of 1st FDA approval = 20070827
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
blood products
calcium chloride
hemophilia B
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
EU000 Not yet/Never filed with EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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