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Catridecacog

Generic Name
Catridecacog
Brand Names
Novothirteen, Tretten, NovoThirteen
Drug Type
Biotech
CAS Number
606138-08-3
Unique Ingredient Identifier
NU23Q531G1

Overview

Coagulation Factor XIII A-Subunit (Recombinant), also known as catridecacog, is a recombinant form of the Factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits . For people with congenital deficiency or mutation of Factor XIII, a rare bleeding disorder, exogenous replacement of this key coagulation factor is essential for management and prevention of bleeding episodes. Also known as Fibrin Stabilizing Factor (FSF), Factor XIII is an endogenously available coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 catalytic A-subunits and 2 non-catalytic B-subunits (FXIII-A2B2) . When activated by thrombin at the site of injury, the FXIII A2B2 pro-enzyme is cleaved resulting in activation of the catalytic A-subunit and dissociation from its carrier B-subunit. As a result, the active transglutaminase from subunit A cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot. This contributes to enhanced platelet and clot adhesion to injured tissue, thereby improving blood coagulation and maintenance of hemostasis . When supplied as the recombinant form, Coagulation Factor XIII A-Subunit (Recombinant) binds to free human FXIII B-subunit resulting in a heterotetramer (rA2B2) with a similar activity profile and half-life as the endogenously available form. In patients with congenital factor XIII A-subunit deficiency, this product (marketed as Tretten) is indicated for the routine prophylaxis of bleeding. In these patients, activated rFXIII has been shown to increase the mechanical strength of fibrin clots, slow down fibrinolysis, and to enhance platelet adhesion to the site of injury. As the half-life of endogenous Factor XIII is long (5-11 days), prophylactic therapy with the replacement of FXIII can be given every 4-6 to maintain hemostasis. Other drug products with similar structure and function to Coagulation Factor XIII A-Subunit (Recombinant) include Factor XIII (human), which is a purified endogenous (human) form of coagulation factor XIII. Compared to Coagulation Factor XIII A-Subunit (Recombinant), which is produced through recombinant DNA technology where the target protein is grown in yeast and then isolated, the human form is isolated from pooled human plasma. Coagulation Factor XIII A-Subunit (Recombinant) is available in the US as the commmercially available product Tretten, and in the EU as NovoThirteen. Tretten is manufactured as an intracellular, soluble protein in yeast (Saccharomyces cerevisiae) production strain containing the episomal expression vector, pD16. It is subsequently isolated by homogenization of cells and purification by several chromatography steps, including hydrophobic interaction and ion exchange chromatography .

Background

Coagulation Factor XIII A-Subunit (Recombinant), also known as catridecacog, is a recombinant form of the Factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits . For people with congenital deficiency or mutation of Factor XIII, a rare bleeding disorder, exogenous replacement of this key coagulation factor is essential for management and prevention of bleeding episodes. Also known as Fibrin Stabilizing Factor (FSF), Factor XIII is an endogenously available coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 catalytic A-subunits and 2 non-catalytic B-subunits (FXIII-A2B2) . When activated by thrombin at the site of injury, the FXIII A2B2 pro-enzyme is cleaved resulting in activation of the catalytic A-subunit and dissociation from its carrier B-subunit. As a result, the active transglutaminase from subunit A cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot. This contributes to enhanced platelet and clot adhesion to injured tissue, thereby improving blood coagulation and maintenance of hemostasis . When supplied as the recombinant form, Coagulation Factor XIII A-Subunit (Recombinant) binds to free human FXIII B-subunit resulting in a heterotetramer (rA2B2) with a similar activity profile and half-life as the endogenously available form. In patients with congenital factor XIII A-subunit deficiency, this product (marketed as Tretten) is indicated for the routine prophylaxis of bleeding. In these patients, activated rFXIII has been shown to increase the mechanical strength of fibrin clots, slow down fibrinolysis, and to enhance platelet adhesion to the site of injury. As the half-life of endogenous Factor XIII is long (5-11 days), prophylactic therapy with the replacement of FXIII can be given every 4-6 to maintain hemostasis. Other drug products with similar structure and function to Coagulation Factor XIII A-Subunit (Recombinant) include Factor XIII (human), which is a purified endogenous (human) form of coagulation factor XIII. Compared to Coagulation Factor XIII A-Subunit (Recombinant), which is produced through recombinant DNA technology where the target protein is grown in yeast and then isolated, the human form is isolated from pooled human plasma. Coagulation Factor XIII A-Subunit (Recombinant) is available in the US as the commmercially available product Tretten, and in the EU as NovoThirteen. Tretten is manufactured as an intracellular, soluble protein in yeast (Saccharomyces cerevisiae) production strain containing the episomal expression vector, pD16. It is subsequently isolated by homogenization of cells and purification by several chromatography steps, including hydrophobic interaction and ion exchange chromatography .

Indication

For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.

Associated Conditions

  • Bleeding

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2014/09/12
Phase 1
Completed
2013/05/24
N/A
Completed
2013/05/07
Phase 1
Completed
2013/05/07
Phase 1
Completed
2012/10/15
Phase 2
Terminated
2010/12/03
Phase 3
Completed
2010/10/28
Phase 3
Completed
2010/06/30
Phase 1
Completed
2010/03/08
Phase 1
Completed
2009/09/16
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
9/3/2012
Authorised
9/3/2012

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
NOVOTHIRTEEN catridecacog (rys) 2500 IU powder for injection vial with diluent vial
201776
Medicine
A
11/7/2013
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