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Xarelto Update: FDA Denies Applications

Last month, the Food & Drug Administration rejected two applications submitted to expand the use of Xarelto (rivaroxaban).

Applications Denied

The applications requested to expand the use of Xarelto to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome (ACS), and to reduce the risk of stent thrombosis.  This is not the first time the FDA has rejected attempts by Janssen to expand approval for Xarelto. In fact, it is the third.  Johnson & Johnson (the parent company of Janssen) and Bayer announced last August that they were initiating three new clinical trials:

These clinical trials are examining ACS, Peripheral artery disease (PAD) and strokes caused by clots of an unknown origin.

What Is Xarelto

Xarelto is an oral anticoagulant, also commonly known as a blood thinner.  It is a novel oral anticoagulant (NOAC), like  Pradaxa (Boehringer Ingelheim GmbH), Eliquis (Pfizer Inc. and Bristol-Myers Squibb Co.) and Savaysa (Daiichi Sankyo).  NOACs were developed to compete with vitamin K antagonists such as warfarin, another type of blood thinner.  A drug like warfarin requires frequent monitoring. NOACs like Xarelto tout not needing such monitoring as a major selling point. Xarelto is currently FDA approved for the prevention and treatment of deep vein thrombosis and pulmonary embolism and for the prevention of strokes in people with non-valvular atrial fibrillation.

Serious Side Effect with No Antidote

Xarelto has a serious side effect of uncontrolled bleeding.  Those who take Xarelto can suffer from serious internal bleeding, especially in the abdomen and brain.  Unlike warfarin, Xarelto currently has no antidote.  An antidote is being developed by Portola Pharmaceuticals.  It is called Andexanet alfa, and is an FXa Inhibitor Antidote. It would be able to be used for Xarelto, Eliquis and Savaysa which are all Factor Xa inhibitors.  The antidote could potentially be used on patients who suffer a bleeding event or need emergency surgery.  The FDA designated Andexanet alfa as a breakthrough therapy, which allows for an expedited approval process. Andexanet alfa is currently undergoing clinical studies.

Boehringer Ingelheim has also been developing an antidote for Pradaxa. It is called idarucizumab, and would be for the rapid reversal of the effects of Pradaxa in the event of a serious bleed.  The FDA also granted idarucizumab the breakthrough therapy designation.  Boehringer Ingelheim announced recently that it has submitted idarucizumab for approval to the FDA, the European Medicines Agency (EMA) and Health Canada.  Clinical studies for the antidote have been ongoing.

While antidotes for NOACs are under development and pursuing regulatory approval, there is still no usable antidote for these drugs.  Patients who take Xarelto are at a risk for severe, currently irreverible internal bleeding.

Know Your Rights

Ashcraft & Gerel, LLP is investigating possible lawsuits against the makers of Xarelto.  Our experienced dangerous pharmaceutical and medical device attorneys have successfully handled many similar cases in the past, including Pradaxa. If you or someone you know has been affected by Xarelto, you may be entitled to compensation. Please contact us online or call us at (800) 674-9725 to speak with an attorney today. All consultations are free and completely confidential.