Portola Pharmaceuticals received news of a second-time delay from the U.S. Food & Drug Administration (FDA) regarding the approval of AndexXa, an antidote developed to monitor uncontrollable bleeding linked to Xarelto and Eliquis. The delay is caused due to some additional data required by the FDA, shifting the expected approval date from February 3, 2018, to May 4, 2018.
Prior to this, the FDA had delayed the August of 2016 approval, when it reverted requesting more information about Portola’s manufacturing and additional data for inclusion of two other anticoagulants in the label: edoxaban and enoxaparin. The makers of anticoagulants Xarelto and Eliquis, Bayer and Johnson & Johnson as well as Pfizer and Bristol-Myers Squibb, have been funding Portola to develop the antidote in view that it will bring the much awaited legal respite be ‘the legal sheath’ to help them evade new lawsuits tied to the bleeding risks of their drugs.
Previously three verdicts have been announced in favor of the defendants by Honorable Eldon E. Fallon presiding MDL – 2592: Xarelto Products Liability Litigation in the U.S. District Court for the Eastern District of Louisiana.