Bayer and Johnson & Johnson have been boosted by data which shows that their bloodthinner Xarelto has succeeded in a late-stage trial in patients with acute coronary syndrome, an area where drugs in the same class have failed.
The German drugmaker says that the Phase III ATLAS ACS TIMI 51 trial of Xarelto (rivaroxaban) plus standard antiplatelet therapy has met its primary efficacy endpoint. Specifically the data shows a statistically significant reduction in the rate of events for the primary composite endpoint of cardiovascular death, myocardial infarction and stroke in patients with ACS, compared to standard therapy plus placebo.
The company noted that for the primary safety endpoint, defined as major bleeding events not associated with coronary artery bypass graft surgery, there was a statistically significant increase in such events in patients receiving rivaroxaban versus placebo. Bayer says it will present the data “as soon as possible at a forthcoming scientific congress”, and will file for market authorisation by the end of this year.
Xarelto, which is already approved for the prevention of venous thromboembolism in patients undergoing elective hip or knee replacement surgery, is an oral Factor Xa inhibitor. It belongs to the same class as Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban), which failed in patients with ACS in a trial last year due to excessive bleeding, as did Astellas’ Factor Xa inhibitor darexaban, development of which has now been halted.
The data is the latest piece of good news Bayer and J&J have had on Xarelto this month. Last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the drug for approval for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, as well as for the treatment of deep vein thrombosis and prevention of recurrent DVT and pulmonary embolism following an acute DVT in adults. That followed a recommendation from a US Food and Drug Administration advisory panel for Xarelto in the AF indication, despite qualms raised by the FDA reviewers of the application.
