About Andexxa
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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
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
 
 
View Results of the ANNEXA-R Study1
View Results of the ANNEXA-A Study1
 
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
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.
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
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
Life-Threatening Bleeding