FDA Allows Large-Scale Production of Antidote Andexxa

FDA Allows Large-Scale Production of Antidote Andexxa

Introduction

In a press release issued last week, Portola Pharmaceuticals announced that the Food and Drug Administration (FDA) has finally sanctioned the Prior Approval Supplement (PAS) for large-scale commercial production of Andexxa, an antidote designed to stop potentially deadly side effects like bleeding from blood thinner drugs Xarelto and Eliquis.

It was initially granted accelerated approval in May 2018 for patients who were treated with rivaroxaban or apixaban medication. The agency had approved Andexxa for a restricted release to only to 40 to 50 hospitals earlier. The antidote for Factor Xa blood thinner effects would allow doctors to counter the uncontrollable bleeding problems linked to the new generation anticoagulants available in the market. Portola’s president and chief executive officer,  Scott Garland, said in the press release, “it is clear from the response to the Andexxa Early Supply Program that there is a significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban. We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa." The FDA has been cautious about the reversal agent and has called for more evidence on this matter, as doctors feel the researchers involved in a 2016 study about Andexxa's benefits might be exaggerating about its effectiveness.

More than 20,000 Xarelto lawsuits are pending as part of federal multidistrict litigation (MDL No.2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation) in the Eastern District of Louisiana which is presided by U.S. District Judge Eldon Fallon. Each of the lawsuits claims the patients and the medical community were not given an appropriate warning about the uncontrollable bleeding effects of Xarelto and Eliquis.

Xarelto (Rivaroxaban) is an anticoagulant that got its U.S. Food and Drug Administration (FDA) approval in November 2011. Xarelto is manufactured by Bayer and jointly marketed by Johnson & Johnson's subsidiary Janssen Pharmaceuticals. It works by blocking certain clotting proteins in the blood and was promoted as a replacement for Warfarin, a blood thinner that had been on the market for a number of years.

Xarelto is indicated in Atrial fibrillation for people who have just had hip or knee replacement surgery to reduce the risk of forming a blood clot, and also to treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). It is the first orally administered active direct factor Xa inhibitor slowing down blood clot formation. It was heavily marketed, and equivalently the usage also increased, until it was noticed that it causes uncontrollable bleeding. As Xarelto has no antidote that can help stop the bleeding, it led to unexpected serious injuries leading to death.