Bayer's Xarelto significantly reduced mortality in major ACS study; Bristol-Myers' Eliquis fails endpoint in VTE trial

The US unit of Germany’s Bayer (BAY: DE) yesterday announced that the combination of oral Xarelto (rivaroxaban) twice daily with standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome (ACS) compared to those receiving standard antiplatelet therapy alone. In addition, rivaroxaban 2.5mg in combination with standard therapy significantly reduced mortality over standard therapy alone.

Results from the pivotal Phase III ATLAS ACS 2-TIMI 51 study were presented at the American Heart Association Scientific Sessions and published by the New England Journal of Medicine, and also showed that rivaroxaban significantly increased the rate of major bleeding, but did not increase the risk of fatal bleeding over standard therapy alone.

The US Food and Drug Administration has granted rivaroxaban “fast track” designation for this indication, given the seriousness of ACS as a medical condition and the potential clinical benefit of rivaroxaban, the company noted. Bayer and US marketing partner Johnson & Johnson (NYSE: JNJ) recently gained FDA approval for Xarelto to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (The Pharma Letter November 7). Xarelto is currently under review by European and Japanese regulators for this use, and has been touted as having a peak sales potential of around 2 billion euros ($2.8 billion) outside the USA.