Patient Education Blog

FDA to review the drug Eliquis (apixaban) for DVT/PE treatment and prevention

Stephan Moll, MD writes… Another ‘blood thinner’ medication is now under consideration by the FDA for the treatment of DVT and PE.

On Dec 19th the FDA accepted the application by Bristol-Myers Squibb (BMS) and Pfizer for review of Eliquis (apixaban) for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE.  The goal date for a decision by the FDA is August 25, 2014.  The press release about this submission from BMS is hereThe application is based on the AMPLIFY trial, a large study of patients with acute DVT or PE which showed  Eliquis (apixaban) was as effective as warfarin and caused less major bleeding.  (The AMPLIFY trial is discussed previously in detail on Clot Connecthere) [Agnelli G et al. N Engl J Med. 2013 Aug 29;369(9):799-808].

The current status of the 4 big new oral anticoagulants (“blood-thinners”) in respect to DVT and PE is as follows:

1. Pradaxa (dabigatran)

  • On August 28th, 2013 the application went in to the FDA by Boehringer-Ingelheim to get Pradaxa (dabigatran) approved for use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) – details here.
  • At present, in the US, Pradaxa is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.

2. Eliquis (apixaban)

  • On Dec 19th BMS and Pfizer applied to the FDA for approval of Eliquis for the treatment of VTE – details here.
  • On July 11th , 2013 BMS and Pfizer applied for FDA approval of their drug for DVT and PE prevention after hip and knee replacement surgery – details here.
  • At present, in the US, Eliquis is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.

3. Xarelto (rivaroxaban)

  • Xarelto is, at present, the only one of the new oral anticoagulants that is FDA-approved for the treatment of DVT and PE. It is also approved for (a) DVT and PE prevention after hip and knee replacement surgery, and (b) for prevention of stroke and other arterial clots in patients with irregular heart beat.

4. Edoxaban

  • This new oral anticoagulant by the Japanese company Daiichi is not FDA-approved for any indication at this time and no FDA review of data is pending.

 A summary comparing the new oral anticoagulants and warfarin can be found at this link.

 

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

Last updated: Jan 6th, 2014

Tags: , , ,

Comments are closed.