Last reviewed 2026-05-26 · How we verify

Recombinant Factor VIII (rAHF)

Recombinant Factor VIII (rAHF) is a Recombinant clotting factor Small molecule drug developed by Baxalta now part of Shire. It is currently FDA-approved for Hemophilia A (congenital Factor VIII deficiency) — treatment and prevention of bleeding episodes, Perioperative management in hemophilia A patients. Also known as: Recombinate rAHF, Antihemophilic Factor (Recombinant).

Recombinant Factor VIII replaces the missing or deficient clotting factor VIII protein to restore the intrinsic coagulation pathway and enable normal blood clot formation.

Recombinant Factor VIII (rAHF) is a protein-based treatment used to manage conditions such as Hemophilia A, Congenital Bleeding Disorder, and Kidney Disease. It works by replacing the missing or defective coagulation factor VIII in the body, which is essential for blood clotting.

At a glance

Mechanism of action

Factor VIII is a critical cofactor in the intrinsic coagulation cascade that works with Factor IX to activate Factor X, ultimately leading to thrombin generation and fibrin clot formation. In hemophilia A, Factor VIII is absent or dysfunctional, causing severe bleeding. Recombinant Factor VIII is produced via recombinant DNA technology in mammalian cell culture and provides functional replacement of this essential clotting factor.

Approved indications

• Hemophilia A (congenital Factor VIII deficiency) — treatment and prevention of bleeding episodes
• Perioperative management in hemophilia A patients

Common side effects

• Inhibitor development (anti-Factor VIII antibodies)
• Injection site reactions
• Headache
• Fever
• Thrombotic events (rare)

Key clinical trials

• Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa (PHASE4)
• A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
• Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A (PHASE3)
• Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle" (PHASE1, PHASE2)
• An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
• A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease (PHASE3)
• An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
• Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs (PHASE2, PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Recombinant Factor VIII (rAHF) CI brief — competitive landscape report
• Recombinant Factor VIII (rAHF) updates RSS · CI watch RSS
• Baxalta now part of Shire portfolio CI

Frequently asked questions about Recombinant Factor VIII (rAHF)

Related

• Drug class: All Recombinant clotting factor drugs
• Target: All drugs targeting Coagulation Factor VIII
• Manufacturer: Baxalta now part of Shire — full pipeline
• Therapeutic area: All drugs in Hematology
• Indication: Drugs for Hemophilia A (congenital Factor VIII deficiency) — treatment and prevention of bleeding episodes
• Indication: Drugs for Perioperative management in hemophilia A patients
• Also known as: Recombinate rAHF, Antihemophilic Factor (Recombinant)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing