Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Andexanet · 1 trial · 1 indication
Anti-fXa activity was measured to assess the ability of andexanet to reverse the anticoagulant effect of FXa inhibitors. Baseline was defined as the last value obtained prior to the start of the andexanet bolus. The change from baseline was calculated as the reduction in anti-fXa activity from baseline to the on-treatment nadir (that is, the minimum value between end of bolus and end of infusion). Percent reduction was calculated as the ratio between the maximum change from baseline and the baseline value, multiplied by 100.
Hemostatic efficacy was achieved when the body had time to produce thrombin and a subsequent clot and was rated by the EAC as: excellent; good; poor/none; not evaluable due to non-administrative reasons; not evaluable due to administrative reasons. These ratings were based on pre-specified criteria that were included in the EAC Charter. The EAC was blinded to anti-fXa activity levels. Participant results were classified as either success or failure based on the hemostatic efficacy rating (success = excellent/good, failure = poor/none). Participants rated by the EAC as non-evaluable due to administrative reasons were excluded from the analysis of hemostatic efficacy.
| Arm | Type | Description |
|---|---|---|
| Andexanet | EXPERIMENTAL | Participants received andexanet as an intravenous bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. |
| Name | Type | Description |
|---|---|---|
| Andexanet | BIOLOGICAL | There were 2 possible dosing regimens: Low dose = 400 milligram (mg) bolus plus 4 mg/minute continuous infusion for 120 minutes; High dose = 800 mg bolus plus 8 mg/minute continuous infusion for 120 minutes. |
Key Inclusion Criteria: 1. Acute major bleeding episode that required urgent reversal of anticoagulation; defined by at least one of the following: * Acute bleeding that was potentially life-threatening, or * Acute bleeding associated with a fall in hemoglobin level by ≥2 grams/deciliter (g/...
Andexanet is an investigational monoclonal antibody being developed for bleeding. It is studied in patients with acute major bleeding to evaluate its ability to reverse the anticoagulation effect of direct and indirect oral anticoagulants. It is in Phase 3 clinical development and is not yet approved.
Andexanet is a monoclonal antibody designed to target and reverse the anticoagulation effect of direct and indirect oral anticoagulants. It is being studied in patients with acute major bleeding to assess its ability to counteract these effects. The drug is in Phase 3 clinical development.
Andexanet is being developed by AstraZeneca PLC, a company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 3 clinical development for the treatment of bleeding. It is an investigational monoclonal antibody and has not been approved.
Andexanet is in Phase 3 clinical development. It is an investigational drug being studied for bleeding, specifically to reverse the anticoagulation effect of direct and indirect oral anticoagulants in patients with acute major bleeding. The drug is not yet approved and remains under investigation.
Andexanet has one completed Phase 3 clinical trial registered under NCT02329327. This study evaluated the ability of andexanet alfa to reverse the anticoagulation effect of direct and indirect oral anticoagulants in 479 participants with acute major bleeding. The trial was conducted in multiple countries including the United States, Belgium, Canada, France, Germany, Japan, Netherlands, Spain, and the United Kingdom.
Yes, Andexanet is the same as andexanet alfa. The clinical trial NCT02329327 refers to the drug as andexanet alfa, which is the full name of the investigational monoclonal antibody being developed by AstraZeneca for bleeding. The drug is in Phase 3 development.