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FVIII (PK subgroup only)
FVIII (PK subgroup only) is a Coagulation factor replacement Small molecule drug developed by Bioverativ Therapeutics Inc.. It is currently in Phase 3 development for Hemophilia A (factor VIII deficiency) — prevention and treatment of bleeding episodes.
FVIII is a recombinant coagulation factor VIII that replaces deficient or dysfunctional clotting factor to restore hemostasis in hemophilia A patients.
FVIII (PK subgroup) is a small molecule used to treat severe Hemophilia A and study its pharmacokinetics. It is administered as concentrated FVIII or Factor VIII (rFVIIIFc), such as Advate, to patients with Hemophilia A.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | FVIII (PK subgroup only) |
|---|---|
| Sponsor | Bioverativ Therapeutics Inc. |
| Drug class | Coagulation factor replacement |
| Target | Factor VIII (coagulation cascade cofactor) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Factor VIII is a critical cofactor in the intrinsic coagulation cascade that works with von Willebrand factor and factor IX to activate factor X, ultimately leading to thrombin generation and fibrin clot formation. In hemophilia A, deficiency or dysfunction of factor VIII impairs this cascade, resulting in bleeding tendency. Recombinant FVIII replacement therapy restores coagulation capacity and prevents or treats bleeding episodes. The PK subgroup designation indicates this study focuses on pharmacokinetic characterization of the factor VIII product.
Approved indications
- Hemophilia A (factor VIII deficiency) — prevention and treatment of bleeding episodes
Common side effects
- Inhibitor development (anti-FVIII antibodies)
- Injection site reactions
- Headache
- Fever
Key clinical trials
- Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A (PHASE3)
- Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A (PHASE3)
- Pharmacokinetic (PK)Research on Chinese Children of Hemophilia (PHASE4)
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:
- FVIII (PK subgroup only) CI brief — competitive landscape report
- FVIII (PK subgroup only) updates RSS · CI watch RSS
- Bioverativ Therapeutics Inc. portfolio CI
Frequently asked questions about FVIII (PK subgroup only)
What is FVIII (PK subgroup only)?
How does FVIII (PK subgroup only) work?
What is FVIII (PK subgroup only) used for?
Who makes FVIII (PK subgroup only)?
What drug class is FVIII (PK subgroup only) in?
What development phase is FVIII (PK subgroup only) in?
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What does FVIII (PK subgroup only) target?
Related
- Drug class: All Coagulation factor replacement drugs
- Target: All drugs targeting Factor VIII (coagulation cascade cofactor)
- Manufacturer: Bioverativ Therapeutics Inc. — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Hemophilia A (factor VIII deficiency) — prevention and treatment of bleeding episodes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing