Lixiana® (Edoxaban), the 4th of the big new oral blood thinners 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). It is available as once daily dosing for prevention of blood clots in the legs and lungs (DVT and PE) after major orthopedic surgeries (hip and knee replacement and hip fracture surgery). Lixiana is a synthetic drug directed against clotting factor Xa (i.e. an anti-Xa drug). It is being developed by Daiichi. It is NOT FDA approved in the U.S. at this point and not available.
Even though this does not have any practical consequences for patients in the U.S. at this point, this is still interesting and relevant news. It increases the number of new oral blood thinners that do not need routine monitoring of their blood thinning effect and have made it through the clinical development stages to come onto the market. This heralds that we will likely have a variety of oral blood thinners available for clinical use in the near future. Status of the new oral blood thinners in the U.S. at this point is:
- Pradaxa® = Dabigatran: FDA approved for atrial fibrillation and commercially available.
- Xarelto® = Rivaroxaban: FDA approved for prevention of DVT and PE after hip and knee replacement surgery and commercially available.
- Eliquis® = Apixaban: not FDA approved, not commercially available.
- Lixiana® = Edoxaban: not FDA approved, not commercially available.
The phase 3 clinical trials that led to the approval of Lixiana 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
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