Edoxaban (Savaysa®), the 4th of the big new oral anticoagulants in development (the other big 3 being Dabigatran = Pradaxa, Rivaroxaban = Xarelto, and Apixaban = Eliquis), is now commercially available in Japan (July 19th, 2011 press release here), available as once daily dosing for VTE prevention after orthopedic surgeries (hip and knee replacement and hip fracture surgery). Edoxaban is a synthetic, specific anti-Xa anticoagulant being developed by Daiichi. It is NOT FDA approved in the U.S. at this point.
Although not of practical consequences for patients in the U.S. at this point, this is still interesting and relevant news, as this availability now increases the number of new oral anticoagulants that have made it through the clinical development stages to come onto the market, heralding that we will likely have a variety of oral anticoagulants available for clinical use in the near future. Status of the various new oral anticoagulants in the U.S. at this point is:
- Dabigatran = Pradaxa: FDA approved for atrial fibrillation and commercially available.
- Rivaroxaban = Xarelto: FDA approved for VTE prevention after hip and knee replacement surgery and commercially available.
- Apixaban = Eliquis: not FDA approved, not commercially available.
- Edoxaban =Lixiana: not FDA approved, not commercially available.
The phase 3 clinical trials that led to the approval of Edoxaban in Japan have not yet been published in the peer-reviewed medical literature. As for treatment of DVT and PE: A huge 7,500 patient phase 3 clinical trial with Edoxaban- Hokusai trial – is presently ongoing and enrolling (www.clinicaltrials.gov; NCT00986154) – enrollment is anticipated to continue for another year (until September 2012).
Disclosures: I have consulted for OthoMcNeil and Bayer, the companies developing Xarelto.
Last updated: July 20th, 2011
Disclaimer: ClotConnect.org, its contributors, authors, advisors, members and affiliate organizations do not assume any liability for the content of the website, blog and educational materials. Medical information changes rapidly. While information is believed to be correct, no representation is made and no responsibility is assumed for the accuracy of information contained on or available through this website and blog. Information is subject to change without notice.