Monday, August 4, 2008
Rivaroxaban submitted for FDA approval
What will happen to all those patients on coumadin (warfarin) if we get a new pill that requires no INR monitoring? Well, rivaroxaban (Xarelto®) may be that first pill in the USA. Rivaroxaban has been submitted for FDA approval. It acts by inhibiting factor Xa, so there is no INR to check since it does not work like warfarin (that inhibits vitamin K-dependent clotting factors).
What will happen to all those Coumadin clinics out there? What about all those fingerstick INR machines? Labs processing those weekely INR checks?
There was a lot of excitement several years ago with the development of Ximelagatran (Exanta). Live toxicity ended the development of that drug in the USA.
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I have been keeping tabs on rivaroxaban development and am anxiously awaiting its approval. If this drug lives up to its potential, it will be a major advancement in anticoagulation. There are numerous niches for this drug (DVT prophylaxis, ACS, A Fib), without the hassle of SubQ injections or frequent INR monitoring. I will be buying up the stock, hopefully to prosper along side Xarelto! Although it may face major opposition with the oral direct thrombin inhibitor dabigatran, which was recently approved in Europe.ReplyDelete