Antidote AndexXa to have a Restricted Release: Portola CEO

Antidote AndexXa to have a Restricted Release: Portola CEO

Introduction

AndexXa, the only antidote for Factor Xa blood thinner, approved by the U.S. Food and Drug Administration(FDA) on May 4 to reverse uncontrollable bleeding problems, will be initially available in only those 40 to 50 hospitals where the clinical trials were held. It will later be provided to about 1,000 different providers after Portola manages to get an FDA nod for the new manufacturing process.

Despite the urgent requirement for a reversal agent for Xarelto and Eliquis, CEO of Portola Pharmaceuticals Bill Lis announced that AndexXa will have a limited release until next year.

AndexXa was approved by the FDA as an antidote for Xarelto and Eliquis after two years, with a boxed warning for thromboembolic risks, ischemic risks, cardiac arrest, sudden death, and other serious and life-threatening adverse events.

Philadelphia state jury overseeing the second Xarelto linked gastrointestinal bleeding lawsuit announced the verdict in favor of the defendants Bayer Healthcare Pharmaceuticals Inc. and J&J subsidiary Janssen Pharmaceuticals Inc. The plaintiff from New Jersey claimed his injury could have been avoided had he and the medical community be warned about the internal bleeding risks associated with Xarelto.

Xarelto lawsuits are centralized in the U.S. District Court for the Eastern District of Louisiana before Judge Eldon E. Fallon as a part of MDL No.- 2592. Currently, more than 22,000 Xarelto cases are pending in several courts across the country.

Nearly 20,000 Xarelto lawsuits are pending before Judge Eldon Fallon in the U.S. District Court as part of a federal multidistrict litigation (MDL) in the Eastern District of Louisiana.