A higher incidence of bleeding in Xarelto patients are among factors that that led Bayer and Janssen Pharmaceuticals to halt a major stroke-prevention study involving the new-generation blood thinner.
The Phase III NAVIGATE ESUS trial was intended evaluate the efficacy and safety of Xarelto for the secondary prevention of stroke and systemic embolism in patients with a recent embolic stroke of undetermined source.
The decision to end the study early was made on the recommendation of an independent review committee, after findings suggested that Xarelto was no better at preventing future strokes than low-dose aspirin.
Patients in the Xarelto arm of the study also experienced more bleeding events.
The Phase III NAVIGATE ESUS trial involved around 7,200 patients from 459 sites across 31 countries worldwide who were randomly prescribed Xarelto (15 mg once daily) or aspirin (100 mg once daily). Bayer and Janssen indicated that they would be releasing a complete analysis of the Phase III Navigate ESUS trial in 2018.
The U.S. Food & Drug Administration (FDA) approved Xarelto in October 2011 to prevent serious blood clots for use in individuals who had undergone knee or hip replacement surgery. The drug’s indications have since been expanded to include the treatment of individuals with atrial fibrillation who have an elevated risk of stroke, and for the treatment of pulmonary embolism and deep vein thrombosis.
According to Reuters, Xarelto is Bayer’s best-selling drug, bringing in $3.4 billion in revenues last year. Despite the disappointing results of the Phase III Navigate ESUS trial, the company still expects Xarleto’s sales to peak at more than $5.3 billion a year.
More than 20000 Xarelto lawsuits have been filed in federal courts on behalf of individuals who allegedly suffered serious episodes of internal bleeding and other life-threatening complications related to the use of the medication. Plaintiffs contend that Bayer and Johnson & Johnson wrongly marketed Xarelto as an improvement over a decades-old anticoagulant called warfarin, even though there currently exists no antidote to reverse bleeding that can occur in Xarelto patients. By contrast, bleeding associated with warfarin can be stopped via the administration of vitamin K.
Federal Xarelto lawsuits have been centralized in a multidistrict litigation that is now underway in the U.S. District Court, Eastern District of Louisiana. So far, Bayer and Johnson & Johnson have prevailed in three bellwether trials.