Bayer and Johnson & Johnson’s plans to expand the scope of blood thinner Xarelto have hit a setback after the drug failed to hit targets in two studies in venous thromboembolism and heart failure studies.
The MARINER trial showed that Xarelto (rivaroxaban) did not reduce the composite endpoint of venous thromboembolism (VTE), or blood clots, and VTE-related death in acute medically ill patients following hospital discharge.
However, the drug did significantly reduce VTE with consistent safety, reinforcing the medicine's positive benefit-risk profile, the firms noted.
James List, global therapeutic area head, Cardiovascular & Metabolism, Janssen Research & Development, said the beyond the three already approved VTE indications for Xarelto, results “tell a more complete story about its role in preventing VTE in appropriate acute medically ill patients, both in-hospital and post-discharge," said James List, global therapeutic area head, Cardiovascular & Metabolism, Janssen Research & Development.
"We see a filing pathway towards approval with these combined findings and look forward to discussing them with the US Food and Drug Administration.”
In COMMANDER HF, which assessed the drug’s impact on reducing the risk of heart attack, stroke and death after an episode of acute decompensated heart failure (ADHF) in patients who have had symptomatic HF for at least three months, Xarelto did not impact overall mortality outcomes compared to standard of care.
However, there were numerically fewer heart attacks and strokes with the drug in sick patients with significant coronary artery disease and reduced left ventricular ejection fraction who experienced a recent episode of ADHF.
“These results suggest that the high death rate in these patients is primarily driven by poor heart function, and not thrombotic events,” the groups stressed.
"Xarelto has been approved for a variety of indications and prescribed more than 42 million times worldwide since its launch. Building off this strong foundation, these findings from the COMMANDER HF and MARINER trials will help the scientific community better understand the underlying role of thrombosis in morbidity and mortality across many different disease states,” Dr List noted.