Showing posts from July, 2011

Ticagrelor approval: US and Europe react

After a protracted approval process in which the   FDA   twice postponed a decision on the drug, experts are reacting to news of the US approval of   ticagrelor   (Brilinta, AstraZeneca), the newest antiplatelet agent to hit the market. The drug was given the   all-clear   from the agency yesterday and is currently approved to reduce the risk of cardiovascular death and MI in patients with acute coronary syndromes (ACS). The approval comes with a hitch, however—specifically, a boxed warning stating that use of ticagrelor with aspirin doses exceeding 100 mg/day decreases the effectiveness of the medication. This warning was likely included in the labeling as a response to the so-called   North American anomaly , in which outcomes were superior with ticagrelor vs   clopidogrel   (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) across the entire international   PLATO   trial but not in North America, where aspirin doses were generally higher. This discrepancy between geographic regions

FDA approves oral anticoagulant rivaroxaban for DVT prevention at surgery

  The once-daily oral anticoagulant   rivaroxaban   (Xarelto, Bayer/Johnson & Johnson) has been approved by the US   Food and Drug Administration   for   prevention of deep venous thrombosis   (DVT) in the setting of knee- or hip-replacement surgery, Janssen Pharmaceuticals—which holds the drug's US marketing rights—announced today. Rivaroxaban, a factor Xa inhibitor, joins the direct thrombin inhibitor   dabigatran   etexilate (Pradaxa, Boehringer Ingelheim) on the US market as the leading edge of what is expected to be a   wave of oral anticoagulants   aimed at replacing   warfarin , one of cardiology's oldest drugs still in wide use. The newly approved drug, Jannsen notes, has already been available in more than 80 countries. The indication for rivaroxaban in its new labeling is based entirely on its performance in the three   RECORD   trials, in which it prevented venous thromboembolism in the orthopedic surgical setting significantly better than   enoxaparin   (L