Stephan Moll, MD writes… 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. The press release of BMS is here. The goal date for a decision by the FDA is August 25, 2014. The application is based on the AMPLIFY trial (discussed previously on Clot Connect – here) [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 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.
- 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.
Disclosure: I have consulted for Janssen, Daiichi, Boehringer Ingelheim.
Last updated: Jan 6th, 2013