Bayer Healthcare has launched its new anti-clotting drug Xarelto (rivaroxaban) in China following SFDA approval. As Liam Condon, Managing Director of Bayer HealthCare China said last week at ChinaBioÂ® Partnering Forum, the fact that Xarelto was approved in China before the US shows Bayerâ€™s commitment to bringing innovative drugs to China simultaneously with other major world markets.
Xarelto is an oral medication, taken once daily, that was approved for the relatively narrow indication of preventing deep vein thrombosis in patients who undergo knee or hip replacement surgery. Xarelto works by inhibiting the enzyme known as factor Xa. Xa helps thrombin and fibrin fibers combine to form clots. As such, Xareltoâ€™s mechanism is different from the blood thinners that are currently on the market. In tests, Xarelto reduced the incidence of clots in this patient population by 70%, a significant improvement over the 49% reduction of the now-standard enoxaparin. The side effect of bleeding was comparable in the two drugs. Over time, Bayer is expected to seek expanded indications for the drug. Although Xarelto is approved for use in Europe, the FDA in the US has asked for additional information on the drug, though the request will not require Bayer to perform additional tests. The FDA advisory committee recommended approval of the drug. With additional indications, Xarelto is widely expected to become a blockbuster drug, ultimately generating revenues of more than $6 billion a year. Bayer and Johnson & Johnson (JNJ) developed Xarelto jointly, though Bayer has the right to market the drug outside the US.