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Factor IX recovery
Factor IX recovery is a Coagulation factor replacement Biologic drug developed by Wyeth is now a wholly owned subsidiary of Pfizer. It is currently FDA-approved for Hemophilia B (Factor IX deficiency), Prevention and treatment of bleeding episodes in Factor IX-deficient patients.
Factor IX recovery refers to the measurement of how much functional Factor IX (a blood clotting protein) is present in the bloodstream after administration of a Factor IX replacement product.
Factor IX recovery is a treatment for Hemophilia B, a condition where the body lacks or does not produce enough coagulation factor IX. This treatment involves administering an exogenous protein, specifically a recombinant form of coagulation factor IX, to replace the deficient or missing protein and facilitate blood clotting.
At a glance
| Generic name | Factor IX recovery |
|---|---|
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Drug class | Coagulation factor replacement |
| Target | Factor IX (coagulation factor IX) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Factor IX is a vitamin K-dependent serine protease essential for the intrinsic pathway of blood coagulation. Factor IX recovery assays measure the in vivo hemostatic activity of administered Factor IX products, typically expressed as a percentage of expected activity based on the dose given. This metric is used to assess the efficacy and bioavailability of Factor IX replacement therapies in patients with Factor IX deficiency (hemophilia B).
Approved indications
- Hemophilia B (Factor IX deficiency)
- Prevention and treatment of bleeding episodes in Factor IX-deficient patients
Common side effects
- Thrombosis
- Inhibitor development (alloimmunization)
- Injection site reactions
- Hypersensitivity reactions
Key clinical trials
- Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B (PHASE3)
- Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B (PHASE3)
- Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B (PHASE3)
- Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX (PHASE4)
- Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects (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:
- Factor IX recovery CI brief — competitive landscape report
- Factor IX recovery updates RSS · CI watch RSS
- Wyeth is now a wholly owned subsidiary of Pfizer portfolio CI
Frequently asked questions about Factor IX recovery
What is Factor IX recovery?
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Related
- Drug class: All Coagulation factor replacement drugs
- Target: All drugs targeting Factor IX (coagulation factor IX)
- Manufacturer: Wyeth is now a wholly owned subsidiary of Pfizer — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Hemophilia B (Factor IX deficiency)
- Indication: Drugs for Prevention and treatment of bleeding episodes in Factor IX-deficient patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing