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FDA Approval for Apixaban (Eliquis) for A. Fib.

Stephan Moll, MD writes…

Today (Dec 28th, 2012) the FDA approved apixaban for the prevention of  stroke and systemic arterial thromboembolism in patients with atrial fibrillation, based on the ARISTOTLE study [ref 1].  The FDA press release is here. The apixaban dose tested in ARISTOTLE was 5 mg twice daily p.o.  Apixaban was superior to warfarin in preventing stroke and systemic embolism, caused less bleeding, and resulted in lower mortality [ref 1].  Apixaban is cleared by the kidney to ca. 25 %, as opposed to 66 % for rivaroxaban and 80 % for dabigatran [ref 3].  Apixaban was approved for A. fib. in Europe on Nov 20th, 2012, and in Canada on Dec 7th, 2012.  Apixaban is not FDA approved at this time for VTE prevention or treatment.

 

The 4 big new oral anticoagulants and venous thromboembolism (VTE)

  1. Rivaroxaban:  In the U.S., only rivaroxaban (Xarelto) is FDA approved for the treatment of acute DVT and PE and for the longer-term secondary prevention of recurrent VTE.
  2. Apixaban:  The phase 3 clinical trial of apixaban (Eliquis) in patients with acute VTE is still ongoing (link here) and results are expected in the 2nd part of 2013. The Apixaban secondary prevention trial (AMPLIFY-EXTENSION) was published in the N Engl J Med on Dec 8th, 2012, showing that apixaban, compared to placebo, decreased the risk of recurrent VTE without increasing the rate of major bleeding.
  3. Dabigatran:  The company making Dabigatran (Pradaxa; Boehringer-Ingelheim) does not appear to have applied yet for FDA approval for the VTE indication.
  4. Edoxaban:  The major phase 3 acute VTE treatment trial with the anti-Xa agent edoxaban (Hokusai trial) is still ongoing – it finished enrollment, but follow-up is ongoing.  Results are expected in 2013.

 

References

  1. Granger CB et al. Apixaban versus warfarin in patients with atrial fibrillation. NEJM 2011;365:981-92.
  2. Connolly SJ et al. Apixaban in patients with atrial fibrillation. NEJM 2011;364:806-17.
  3. Garcia D et al. The new oral anticoagulants. Blood 2010;115:15-20.

 

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

Last updated: Dec 28th, 2012

 

 

 

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