Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adynovate · 1 trial · 1 indication
Total ABR was defined as the number of treated and non-treated bleeding episodes (BEs) that occurred during the treatment period, calculated as, ABR= number of unique bleeds during treatment period/(length of treatment period \[days\]/365.25). Total ABR for all BEs, spontaneous or traumatic, recorded in the participant's electronic diary and/or recorded in the physician/nurse/study site notes were reported.
| Arm | Type | Description |
|---|---|---|
| Adynovate 45±5 IU/kg | EXPERIMENTAL | Participants received prophylactic treatment with Adynovate (45 \[±5\] IU/kg), infusion, IV, twice weekly, for at least 50 EDs, or approximately 28 weeks. |
| Name | Type | Description |
|---|---|---|
| Adynovate | BIOLOGICAL | Adynovate was injected intravenously using an appropriately sized syringe as a bolus infusion over a period of less than or equal to (\<=) 5 minutes (maximum infusion rate, 10 milliliters per minute \[mL/min\]). |
Inclusion Criteria: 1. Participant and/or legally authorized representative must voluntarily sign a written informed consent form (ICF) after all relevant aspects of the study have been explained and discussed with the Participant. For the participants less than (\<) 18 years old, participants will...
Adynovate is used for Hemophilia A. It is being studied in previously treated Chinese teenagers and adults with severe Hemophilia A. The drug is in Phase 3 clinical development and is being developed by Takeda Pharmaceutical Company Limited.
Adynovate is a monoclonal antibody. It is being developed for the treatment of Hemophilia A. The specific molecular target of Adynovate is not disclosed in the available information.
Adynovate is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials for Adynovate in the treatment of Hemophilia A.
Adynovate is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial for Adynovate in Hemophilia A has been completed.
Adynovate has one completed Phase 3 clinical trial, NCT05707351, titled 'A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A'. The trial enrolled 37 male participants aged 12 years and older in China.
Adynovate is also known by other names, though specific alternative names are not provided in the available information. It is being developed by Takeda Pharmaceutical Company Limited for Hemophilia A.