April 15th, 2009 | Sources: NY Times

Warfarin has ruled the roost for decades as the oral drug of choice for preventing venous thromboembolism. Now, there’s a new kid on the block and it has a chance to get real big.

gettinbigwithrivaroxabanLast week, an FDA advisory panel voted 15-2 to recommend that the agency approve rivaroxaban for short-term prophylaxis against VTE in patients that have undergone hip or knee replacement surgery.

Typically, the FDA follows the recommendations of its advisory panels.

Rivaroxaban is the result of a JV involving Bayer and Johnson & Johnson.

Industry experts believe that rivaroxaban could generate $200 million in sales for the orthopedic use, but the real prize lies with a large population of patients who take warfarin chronically for stroke prevention and sundry cardiac indications.

“This is Act 1 of a multiact play,” Rick Wise, a Leerink Swann analyst told the New York Times.

UBS Securities analyst Bruce Nudell estimated for example that rivaroxaban could generate $6 billion in annual revenue by completely supplanting the generically-available warfarn, unlikely though that may be.

Physicians and patients alike have chafed for decades at the nuisance factor associated with taking warfarin. The drug requires frequent blood tests to assure proper dosing and has this annoying tendency to cause bleeding and death.

newkidsontheblockProblem is, the new kid might not be much better in this regard. Trials comparing it with enoxaparin, an injectible anticoagulant, showed it to be better at reducing blood clots but saddled with nearly twice the incidence of major bleeding events.

That’s why panelist Sanjay Kaul voted against approving the new kid. “I saw a risk-benefit ratio which was a washout,” the Cedars Sinai cardiologist told the Times.



  1. Jeffrey Seguritan | 15/04/09

    Less clots, more bleeding–the same banner that plagues prasugrel in comparison to the well-established clopidogrel (Plavix). It was Sanjay Kaul brought up the argument that bleeding risk from prasugrel could not be cleanly isolated even among the high risk groups (>75 yrs, less than 130 lbs, stroke history) identified in the TRITON-TIMI study. Actually, what I found fascinating was the secondary finding from the JUPITER study (http://online.wsj.com/article/SB123837273043767895.html) that showed Crestor to significantly reduce VTE risk by 43% (although the absolute numbers were small–34 vs. 60 in a 15,000 patient trial). Ironically, this might be yet another corroboration of the hypothesis that statins do their magic by targeting inflammation, not cholesterol.

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