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Moroctocog alfa

Generic Name
Moroctocog alfa
Brand Names
Refacto AF, Xyntha, ReFacto AF
Drug Type
Biotech
CAS Number
284036-24-4
Unique Ingredient Identifier
113E3Z3CJJ

Overview

Moroctocog alfa, also known as BDDrFVIII (B domain deleted recombinant factor VIII), is a recombinant DNA-based drug with functional characteristics comparable to those of endogenous coagulation Factor VIII, the essential human blood clotting protein that is impaired in Hemophilia A. Moroctocog alfa is identical in sequence to endogenously produced Factor VIII, but does not contain the B-domain, which has no known biological function. Moroctocog alfa is produced through recombinant DNA technology and purification, resulting in a 1438 amino acid, 170 kDa protein . Clinical evaluation has shown that BDDrFVIII is pharmacokinetically equivalent to full-length recombinant FVIII . Also known as Anti-Hemophilic Factor (AHF), endogenous Factor VIII is essential to the clotting process in the body due to its involvement in the clotting cascade where it is responsible for acting as a co-factor to Factor IX. Activation of Factor IX leads to a cascade of signals that results in activation of Factor X, which then results in the conversion of prothrombin to thrombin, and as a result, leads to the conversion of fibrinogen to fibrin, the fibrous protein that creates the scaffold of the clot. Replacement of Factor VIII is essential for the treatment of Hemophilia A, which is caused by mutations in the Factor VIII gene, leading to a functional deficiency or complete loss of protein. Congenital loss or deficiency of Factor VIII results in the physiologic impairment of the coagulation clotting cascade, and as a result, leads to easy bruising and bleeding. Bleeding can range in severity from minor concerns, such as nosebleeds, to more serious events such as hemorrhaging in the joints, brain, or digestive tract . Exogenous replacement of Factor VIII is currently the cornerstone of Hemophilia treatment and is used for the prophylaxis and control of bleeding episodes. Treatment has drastically improved since the 1960s when Factor VIII protein was primarily purified from human plasma, rather than being produced through recombinant DNA technology. Unfortunately, purification of protein from human plasma carries an increased risk of transmission of blood-borne diseases such as HIV and Hepatitis, which in part contributed to the Tainted Blood Scandal in the 1980s . Use of recombinant DNA-derived clotting factor treatments, such as Moroctocog alfa, has reduced this risk. Other drug products with similar structure and function to Moroctocog alfa include Antihemophilic factor human, which is purified Factor VIII from human pooled blood and contains both A- and B-subunits, and Efmoroctocog alfa, which is a fully recombinant factor VIII-Fc fusion protein which has an extended half-life compared with conventional factor VIII due to conjugation to the dimeric Fc domain of human immunoglobulin G1, a long-lived plasma protein . Moroctocog alfa is approved by Health Canada and by the European Medicines Agency for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). As it does not contain von Willebrand factor it is not indicated in von Willebrand’s disease .

Indication

Moroctocog alfa is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.

Associated Conditions

  • Bleeding caused by Hemophilia A

Research Report

Published: Oct 17, 2025

Moroctocog Alfa (BDDrFVIII): A Comprehensive Monograph on its Molecular Design, Clinical Efficacy, and Therapeutic Role in Hemophilia A

Executive Summary

Moroctocog alfa is a high-purity, B-domain deleted recombinant coagulation Factor VIII (BDDrFVIII) that serves as a cornerstone therapy in the management of hemophilia A. This biotech therapeutic is engineered to replace the deficient or absent endogenous Factor VIII, thereby restoring the integrity of the intrinsic coagulation cascade and enabling effective hemostasis. Its approved indications are comprehensive, encompassing on-demand treatment of acute bleeding episodes, perioperative management for surgical procedures, and routine prophylaxis to prevent bleeds in patients of all ages, from newborns to adults.[1]

The development of Moroctocog alfa reflects the broader safety-driven evolution of biologic medicines. Marketed under trade names such as ReFacto, ReFacto AF, and Xyntha, its manufacturing process has been progressively refined. The transition to an albumin-free cell culture (AF-CC) process, coupled with advanced purification techniques that eliminate animal- and human-derived components, has established Moroctocog alfa as a third-generation recombinant Factor VIII product with an enhanced safety profile regarding pathogen transmission.[4]

Clinical evidence robustly supports its efficacy. Prophylactic regimens have been shown to significantly reduce bleeding frequency, with studies demonstrating low median annualized bleed rates (ABR) and a substantial proportion of patients remaining bleed-free.[6] In on-demand settings, the vast majority of bleeding events are controlled effectively with one or two infusions.[6] Pharmacokinetic studies have confirmed its bioequivalence to earlier formulations and, critically, its therapeutic equivalence to full-length recombinant Factor VIII products, validating its unique molecular design.[5]

Continue reading the full research report

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
4/13/1999

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
XYNTHA POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500IU
N/A
N/A
N/A
9/25/2020

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
XYNTHA SOLOFUSE
02374056
Powder For Solution - Intravenous
250 UNIT / SYR
N/A
XYNTHA
02309491
Kit ,  Powder For Solution - Intravenous
500 UNIT / VIAL
1/23/2009
XYNTHA SOLOFUSE
02374080
Powder For Solution - Intravenous
2000 UNIT / SYR
5/8/2012
REFACTO
wyeth canada
02245951
Powder For Solution - Intravenous
1000 UNIT / VIAL
2/11/2003
XYNTHA
02309483
Powder For Solution ,  Kit - Intravenous
250 UNIT / VIAL
1/23/2009
XYNTHA
02309505
Kit ,  Powder For Solution - Intravenous
1000 UNIT / VIAL
1/23/2009
XYNTHA SOLOFUSE
02374099
Powder For Solution - Intravenous
3000 UNIT / SYR
5/8/2012
XYNTHA SOLOFUSE
02374064
Powder For Solution - Intravenous
500 UNIT / SYR
9/27/2019
XYNTHA
02309513
Powder For Solution ,  Kit - Intravenous
2000 UNIT / VIAL
1/23/2009
XYNTHA SOLOFUSE
02374072
Powder For Solution - Intravenous
1000 UNIT / SYR
4/13/2012

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
REFACTO AF 1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN JERINGA PRECARGADA
99103007
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
REFACTO AF 2000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN JERINGA PRECARGADA
99103008
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
REFACTO AF 500 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
99103002
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
REFACTO AF 250 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN JERINGA PRECARGADA
99103009
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
REFACTO AF 250 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
99103001
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
REFACTO AF 1000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
99103003
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
REFACTO AF 3000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN JERINGA PRECARGADA
99103005
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
REFACTO AF 2000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
99103004
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
REFACTO AF 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN JERINGA PRECARGADA
99103006
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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