Last reviewed · How we verify
Plasma-derived FVIII/VWF concentrate
This plasma-derived concentrate replaces deficient Factor VIII (FVIII) and von Willebrand Factor (VWF) to restore blood clotting ability in patients with hemophilia A or von Willebrand disease.
This plasma-derived concentrate replaces deficient Factor VIII (FVIII) and von Willebrand Factor (VWF) to restore blood clotting ability in patients with hemophilia A or von Willebrand disease. Used for Hemophilia A, von Willebrand disease.
At a glance
| Generic name | Plasma-derived FVIII/VWF concentrate |
|---|---|
| Also known as | Emoclot, Fanhdi |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Drug class | Coagulation factor concentrate |
| Target | Factor VIII and von Willebrand Factor |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Factor VIII is a critical cofactor in the intrinsic coagulation pathway, and von Willebrand Factor serves as both a carrier protein for FVIII and a mediator of platelet adhesion. By supplying both proteins from pooled human plasma, this concentrate corrects the underlying deficiency and restores normal hemostasis in patients with FVIII/VWF deficiency or dysfunction.
Approved indications
- Hemophilia A
- von Willebrand disease
Common side effects
- Thrombosis
- Inhibitor development (anti-FVIII antibodies)
- Allergic reactions
- Viral transmission risk (historical concern)
Key clinical trials
- Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age (PHASE3)
- A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD (PHASE3)
- Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease (PHASE4)
- Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease (PHASE1)
- Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (NA)
- Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development (PHASE3)
- Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients (PHASE4)
- Optivate in People With Von Willebrand Disease Undergoing Surgery (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape: