Portola Pharmaceuticals announced it’s going to submit for FDA’s approval a new antidote for Xarelto. The new drug will hit the market sometime during this year 2016. Almost three hundred Xarelto lawsuits have been filed up to now. The amount of plaintiffs who seek the help of a Xarelto attorney to ask for compensation from Janssen Pharmaceutical and Bayer AG just reached over 2,800 cases. The huge and ever-growing number of Xarelto lawsuits has been recently consolidated in a Multidistrict Litigation MDL No. 2592 in the Eastern District of Louisiana, overseen by Judge Eldon Fallon.
Many people suffered several degrees of injury (including death) because of the dangerous Xarelto side effects. Probably the most dreaded adverse reaction of the infamous blood thinner is the Xarelto uncontrolled bleeding accident. The absence of a proper Xarelto antidote to reverse the medication’s effects did, in fact, prevent doctors and health carers from saving many patients lives. Even a simple Xarelto gastrointestinal bleeding or Xarelto gum bleeding may have dire consequences to the patient’s health, as once the bleeding occurs, there’s no way to stop it.
However, there’s a chance things are going to change. Portola Pharmaceuticals recently submitted for approval his new Xarelto bleeding reversal drug, an antidote called Andexanet Alfa (PRT064445). The medication was originally ideated to reverse the effects of another new generation blood thinner, Eliquis, but it may work even as a possible Xarelto antidote. Many doctors are afraid of using Xarelto to prevent stroke and blood clots in patients suffering from atrial fibrillation, but the availability of a new Xarelto bleeding reversal method may improve the medication’s safety profile. Andexanet Alfa is expected to be released on the markt this year, if the US Food and Drugs Administration grants its approval.
The safety and effectiveness of Andexanet in patients under treatment with Xarelto is being tested in two pivotal studies called ANNEXA-A and ANNEXA-R. Andexanet acts by directly binding to Factor Xa Inhibitors such as Eliquis and Xarelto, stopping their anticoagulant action. The new Xarelto Antidote may further increase the blood thinner’s potential market over its counterpart Warfarin, a 40 years old drug. However, Portola is also developing a new blood thinner medication to compete with Pradaxa, Eliquis and Xarelto.
Article written by: Dr. Claudio Butticè, Pharm.D.
Published: 2016/01/21
