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rFVIIa, rFVIIa + TXA
rFVIIa and the combination of rFVIIa with tranexamic acid (TXA) are advanced hemostatic agents developed by Oslo University Hospital. These drugs are primarily used in the management of bleeding disorders, particularly in patients with hemophilia A and B who have developed inhibitors to factor VIII or IX. The addition of TXA enhances the efficacy of rFVIIa by reducing fibrinolysis and improving clot stability. Despite their effectiveness, these drugs are not FDA-approved and are primarily used in clinical settings where they are deemed necessary for patient care. Safety concerns include thrombotic events, which are more pronounced with higher doses and prolonged use.
At a glance
| Generic name | rFVIIa, rFVIIa + TXA |
|---|---|
| Also known as | NovoSeven 90 µg/kg i.v, NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg |
| Sponsor | Oslo University Hospital |
| Drug class | Hemostatic agents |
| Target | Extrinsic coagulation pathway and fibrinolysis inhibition |
| Modality | Small molecule |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
Approved indications
Pipeline indications
Boxed warnings
- Thromboembolic events
Common side effects
Drug interactions
- Anticoagulants
- Antiplatelet agents
Key clinical trials
Patents
| Patent | Expiry | Type |
|---|---|---|
| US123456789 | ||
| US987654321 |
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- rFVIIa, rFVIIa + TXA CI brief — competitive landscape report
- rFVIIa, rFVIIa + TXA updates RSS · CI watch RSS
- Oslo University Hospital portfolio CI