Rivaroxaban to be Reviewed by the FDA Panel on March 19

March 19 is match day for 4th year medical students. It's also the day when the FDA Panel is supposed to review the anticoagulant rivaroxaban (also known as BAY 59-7939 or Xarelto). It is an oral, direct Factor Xa inhibitor (I don't think I'll ever forget that coagulation cascade diagram that I learned in medical school). If approved, this drug could shut down all those coumadin (warfarin) clinics out there that monitor blood INR in people taking this vitamin K antagonist. Rivaroxaban would not require any blood monitoring. Plus, all those home INR tests manufacturers would need to look for something new to do.

I think everyone is wondering how the FDA will react to this new medication. If approved by the FDA, rivaroxaban will be sold in the US for short-term use as a prophylactic anticoagulant for patients undergoing knee- and hip-replacement surgeries. I'm sure the drug manufacturers will go for additional indications later on. Rivaroxaban is manufactured by Bayer and will be marketed by Ortho-McNeil Pharmaceutical which is a Johnson & Johnson group.

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.