The U.S. Food and Drug Administration (FDA) has finally approved Andexxa, two years after Portola Pharmaceuticals developed it as an antidote for rivaroxaban (Xarelto) and apixaban (Eliquis) prescribed to treat stroke, pulmonary embolism and venous thromboembolism (VTE). The Factor Xa inhibitors (Xarelto and Eliquis) were launched as new generation safe alternatives to age-old Warfarin. However, the absence of an antidote and increase in the related bleeding incidents resulted in concerns with respect to their usage.
Andexxa was approved on May 4 under FDA’s accelerated approval pathway based on effects in healthy volunteers. However, only after a successful clinical trial, the fate of this antidote will be known. The post-marketing trial will commence from 2019. Doctors are uncertain about Andexxa’ s positive effects, on the basis of a 2016 study and have demanded more evidence relevant to its safe use by patients.
Andexxa, which may now allow the medical fraternity to treat thousands of life-threatening bleeding incidents, was approved with a boxed warning for thromboembolic risks, ischemic risks, cardiac arrest, sudden death, and other serious and life-threatening adverse events.
Currently, about 20,000 lawsuits are pending against Xarelto over excessive bleeding incidents, centralized in U.S. District Court under Judge Eldon Fallon, who has recommended the parties to elect 1,200 cases for the discovery purpose.
