Product Description
Intravenous susoctocog alfa (Obizur(®)) is a recombinant, B-domain deleted, porcine sequence antihaemophilic factor VIII (FVIII) product that has recently been approved for the treatment of bleeding episodes in adults with acquired haemophilia A (AHA). Intravenous susoctocog alfa was an effective and generally well tolerated treatment for serious bleeding episodes in adult patients with AHA in a multinational, phase II/III trial (n = 28 evaluable). Patients received an initial dose of susoctocog alfa 200 U/kg, with subsequent dosages based on target FVIII trough levels and clinical assessments. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/27098420/)
Mechanisms of Action: FVIII Inhibitor
Novel Mechanism: Yes
Modality: Coagulation Factor
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Australia | Austria | Belgium | Colombia | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Italy | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Takeda
Company Location: TOKYO M0 103-8668
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Japan
Active Clinical Trial Count: 2
Highest Development Phases
Phase 3: Hemophilia A
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2051200066 | P3 |
Completed |
Hemophilia A |
2022-11-29 |
|
| TAK-672-3001 | P3 |
Completed |
Hemophilia A |
2022-11-29 |