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Andexanet

Phase 3

Bleeding | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Feb 16, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment479
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02329327A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)PHASE3 COMPLETED 479Apr 10, 2015Sep 24, 2020Feb 16, 202287 United States, Belgium +7
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Study Endpoints
Primary Endpoints
Percent Change From Baseline In Anti-fXa Activity By FXa Inhibitor
Baseline, 12 Hours (post infusion)

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.

Participants Achieving Hemostatic Efficacy
12 Hours (post infusion)

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.

Secondary Endpoints
Percent Change From Baseline In Anti-fXa Activity By Hemostatic Efficacy
Baseline, 12 Hours (post infusion)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
AndexanetEXPERIMENTALParticipants received andexanet as an intravenous bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
Interventions
NameTypeDescription
AndexanetBIOLOGICALThere 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites87

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/...

Countries:United StatesBelgiumCanadaFranceGermanyJapanNetherlandsSpainUnited Kingdom
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