About Andexxa

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Stopwatch line art showing just two minutes elapsed, the time it takes for Andexxa to begin working

Rapid reversal of anti-FXa activity within 2 minutes following bolus administration in older, healthy volunteers1

ANNEXA-4 Interim Data Set, Prior to Day 30 (From the Prescribing Information):1

  • 14% overall mortality in patients who received the Generation 1 (100 mg) product (n=25/185)
    •  14% ICH mortality in patients who received the Generation 1 (100 mg) product
Professional in front of a podium with microphone to represent what professionals have to say about Andexxa

Expert guidelines recommend a specific reversal agent for first-line therapy to reverse apixaban or rivaroxaban2

  • 18% overall mortality in patients who received the Generation 2 (200 mg) product (n=23/124)

Andexxa is a modified recombinant FXa protein that binds with high affinity to the FXa inhibitors apixaban or rivaroxaban1,3

Andexxa binds and sequesters the FXa inhibitors apixaban and rivaroxaban. This allows native FXa to restore thrombin generation, which is necessary for fibrin and clot formation.4

Andexxa also binds to and inhibits the activity of tissue factor pathway inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor (TF)–initiated thrombin generation.1,3,4

Andexxa Clinical Trial
Program Overview

The safety and efficacy of Andexxa were evaluated in 2 prospective, randomized, placebo-controlled studies, conducted in healthy volunteers. Both studies examined the percent change in anti-FXa activity, from baseline to nadir, for the low-dose and high-dose regimens of bolus followed by continuous infusion.1

Generic graph line drawing representing the study data presented for the ANNEXA-4 trial Generic graph line drawing representing the study data presented for the ANNEXA-4 trial
View Results of the ANNEXA-A Study1
Generic graph line drawing representing the study data presented for the ANNEXA-4 trial Generic graph line drawing representing the study data presented for the ANNEXA-4 trial
View Results of the ANNEXA-R Study1
Apixaban arm of Annexa-A study design showing Andexxa activity timeline overlaid with matching placebo trendline Apixaban arm of Annexa-A study design showing Andexxa activity timeline overlaid with matching placebo trendline
Rivaroxaban arm of Annexa-R study design showing Andexxa activity timeline overlaid with matching placebo trendline Rivaroxaban arm of Annexa-R study design showing Andexxa activity timeline overlaid with matching placebo trendline

92% reduction in anti-FXa activity in older,  
healthy volunteers taking apixaban at nadir (P<0.0001)

Pooled Safety Analysis for ANEXXA-A and ANEXXA-R
in Older, Healthy Volunteers

Overall frequency of adverse events was similar  
between Andexxa-treated subjects and placebo-treated subjects1

0%

Thromboembolic events

0%

Serious or severe adverse events

18%

Experienced infusion-related adverse reactions

ANEXXA-4 Study

Phase 3b/4 Study in Patients With Acute Major Bleeding1

Study logo for the Annexa-4 phase 3b/4 trial for Andexxa

The efficacy of ANDEXXA was evaluated in a multinational, prospective, single-arm, open-label study of ANDEXXA patients taking FXa inhibitors who presented with acute major bleeding.

Patient population with timeline showing efficacy of Andexxa during Annexa-4 prospective, single-arm, open-label study

Limitations of Use: Andexxa has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.

Primary efficacy measures 4

  • Percent change from baseline in anti-FXa activity
  • Rate of excellent or good hemostatic efficacy 12 hours after infusion

ANDEXXA Reversed FXa Inhibition in Patients With Acute Major Bleeding

Annexa-4 study showed a 92% decrease in anti-FXa activity when Andexxa was used

Mortality

ANNEXA-4 Interim Data Set, Prior to Day 30 (From the Prescribing Information):1

  • 14% overall mortality in patients who received the Generation 1 (100 mg) product (n=25/185)
    • 14% ICH mortality in patients who received the Generation 1 (100 mg) product
  • 18% overall mortality in patients who received the Generation 2 (200 mg) product (n=23/124)

Thromboembolic Events

ANNEXA-4 Full Study Report:5

  • 10% (n=34/352) experienced a thromboembolic event during the 30-day follow-up period, defined as myocardial infarction, ischemic stroke, transient ischemic attack, deep vein thrombosis, and pulmonary embolus
  • No thromboembolic events were experienced after oral anticoagulation was restarted

ANNEXA-4 Interim Data Set, Prior to Day 30 (From the Prescribing Information):1

  • Overall, approximately 17.8% of patients receiving either Generation 1 (100 mg) or Generation 2 (200 mg) product experienced a thromboembolic event during the 30-day follow-up period, defined as myocardial infarction, ischemic stroke, deep vein thrombosis, pulmonary embolism, cardiogenic shock, sudden death, congestive heart failure, acute respiratory failure, cardiac arrest, cardiac thrombus, embolic stroke, iliac artery thrombosis, and non-sustained ventricular tachycardia
  • 12.7% (n=11/86) experienced thromboembolic events, ischemic events, and cardiac events, including sudden death, among patients who were re-anticoagulated prior to a thromboembolic event. It is important to monitor patients for thromboembolic events