Apixaban (Eliquis) FDA-Approval for DVT and PE Treatment

Stephan Moll, MD writes…  Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE.  The approval covers (a) acute DVT/PE management and (b) prevention of recurrent DVT/PE.

Drug Dosing

• For acute management of VTE: 10 mg taken twice daily for 7 days, followed by 5 mg twice daily. 
• For secondary prevention of VTE recurrence: 2.5 mg taken twice daily.

 

The Clinical Studies

Approval was based on 2 large phase 3 trials, the AMPLIFY [ref 1] and AMPLIFY-EXTENSION [ref 2] trials.  The acute treatment trial (5,244 patients enrolled) showed that apixaban, given immediately upon the diagnosis of new DVT or PE was non-inferior to conventional therapy (low molecular weight heparin followed by warfarin) and was associated with significantly less bleeding (a composite of major bleeding and clinically relevant non-major bleeding).  Thus: Apixaban was as effective as LMWH/warfarin, but safer.  In the extension trial 2,486 patients received either apixaban or placebo for 12 months after they had completed 6-12 months of standard anticoagulation for VTE.  Apixaban reduced the risk of recurrent venous thromboembolism without increasing the rate of major bleeding.

 

Further Information on Apixaban

• Medication guide for patients (click here)
• Full prescribing information for apixaban (click here)
• The press release from Bristol-Myers-Squibb is here.

 

Anticoagulant Drug Choices for Treatment of DVT and PE

Three new oral anticoagulants (NOACs) are now FDA-approved and available for the treatment of DVT and PE.  A fourth one, edoxaban (Savaysa®), is not available at this time, but is under FDA review.  This Clot Connect document provides a summary table of the pros and cons of the NOACs compared to warfarin that can be used in the discussion with a patient, and also a table comparing the 3 available NOACs amongst each other.  The lower risk of major and clinically relevant non-major bleeding makes Eliquis® an attractive choice; the once daily dosing regimen makes Xarelto® an attractive choice.  I do not see any advantage of Pradaxa® over the other two drugs.

 

References

1. Agnelli G et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013;369:799-808.
2. Agnelli G et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013; 368:699-708.

 

Disclosure: I have consulted for Janssen, Daiichi, Boehringer Ingelheim.

Last updated: Aug 22nd, 2014