Recently, Germany’s Bayer (BAYRY) presented mixed data regarding its blood thinner Xarelto (rivaroxaban) for preventing venous thromboembolism (VTE) in hospitalized ill patients. Data from the late-stage study (MAGELLAN: n= 8,101) were presented by Bayer at the annual meeting of the American College of Cardiology. Xarelto has been co-developed with Johnson & Johnson (JNJ).
Data from the multi-national, randomized, double-blind, placebo-controlled study revealed that Xarelto was as effective as Sanofi- Aventis’ (SNY) Lovenox (enoxaparin) in preventing VTE over the short-term (10 ± 4 days). Bayer’s therapy however was superior to the Sanofi blood thinner over the long-term (35 ± 4 days). The disappointing aspect was the higher bleeding rates in patients treated with Xarelto compared to those in the Lovenox arm.
We remind investors that in January 2011, Bayer filed an application with the European Medicines Agency (EMA), seeking approval from the European regulatory body to market Xarelto in Europe. Clearance was sought to market the drug for preventing stroke in patients with an erratic heartbeat. This cardiac rhythm disorder is referred to as atrial fibrillation (AF). European approval has also been sought to market Xarelto to treat patients suffering from deep vein thrombosis (DVT), and for the prevention of recurrent DVT and pulmonary embolism (PE).
Apart from seeking European approval, clearance from the US Food and Drug Administration (FDA) was also sought to market Xarelto for preventing stroke and systemic embolism in non-valvular AF patients in the US. The US approval, like the European approval, was sought on the basis of data from the ROCKET-AF study. On approval, Johnson & Johnson will market the drug in the US. Bayer is exclusively responsible for the marketing of Xarelto in countries outside the US.
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