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The findings of a new study suggest that the antidote for Xarelto and Eliquis, which is marketed as Andexxa, is proving effective at reducing the risk of serious bleeding injuries and deaths, following years of problems with the drugs after they were introduced without any approved reversal agent.
Researchers from the U.S., Canada, France and London published a study in the New England Journal of Medicine on February 7, indicating that Andexxa restored hemostatic efficiency in nearly all patients given Xarelto and Eliquis within 12 hours.
Andexxa (andexanet alfa) is a reversal agent for a class of blood thinners known as factor Xa inhibitors, which includes the new generation anticoagulants Xarelto and Eliquis. It was developed by Portola Pharmaceuticals, which also funded this latest study, and approved by the FDA in May 2018.
Xarelto and Eliquis were introduced as new-generation replacements for warfarin, as a preventative treatment for strokes and other problems associated with atrial fibrillation. However, the two drugs have been linked to thousands of reports involving severe and fatal injuries when users experienced bleeding that doctors were unable to stop or reverse.
Unlike warfarin, which can be quickly reversed with a known antidote, no approved reversal agent for Xarelto and Eliquis had been available since the drugs were introduced, until the development of Andexxa.
In this latest study, researchers evaluated 352 patients who suffered acute major bleeding within 18 hours of being given Xarelto or Eliquis. According to the findings, Eliquis and Xarelto patients saw a 92 percent reduction in anti-factor Xa activity after being given a dose of Andexxa.
The researchers determined that 82 percent of patients given the drug returned to excellent or good hemostasis. However, within 30 days, about 14 percent of patients died from any causes and 10 percent suffered a thrombotic event.
“In patients with acute major bleeding associated with the use of a factor Xa inhibitor, treatment with andexanet markedly reduced anti-factor Xa activity, and 82% of patients had excellent or good hemostatic efficacy at 12 hours, as adjudicated according to prespecified criteria,” the researchers concluded.
Incidents of unstoppable bleeding have resulted in injury and death for patients using the new drugs. Currently, there are about 20,000 Xarelto lawsuits pending as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana.
Each of the claims raise similar allegations that users and the medical community were not adequately warned about the risk of uncontrollable bleeding on Xarelto.
Following a handful of early bellwether trials, which were held before Judge Fallon to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, thousands of individual cases may be remanded back to federal district courts nationwide for individual trials if Xarelto settlements or another resolution for the claims is not reached by the parties.