Xarelto Has New Competitor After FDA Approval of Eliquis


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Bayer HealthCare, a subsidiary of Bayer AG (PINK:BAYRY) (FRA:BAYN) (ETR:BAYN) and Janssen Pharmaceuticals, Inc said it entered into a clinical collaboration partnership with Portola Pharmaceuticals, Inc to evaluate the safety of PRT4445, an investigational drug designed to reverse uncontrolled bleeding risks from taking Xarelto, an anticoagulant medicine against thrombosis or heart attacks.

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According to Bayer HealthCare, the clinical study for PRT 4445 will be administered to healthy volunteers who have been taking Xarelto.  They will combine multiple dosage strengths of the investigational drug, with Xarelto to identify the proper dose needed to reverse its anticoagulant activity during emergency.

In a statement, Dr. Kemal Malik, a member of the executive committee and head of global development of Bayer HealthCare said, “Although when normalization of blood clotting is necessary, stopping the intake of Xarelto is usually effective, we understand the desire of doctors to have a specific antidote to reverse the anticoagulation effects of the product. We are addressing this request both through in-house research as well as through this external collaboration with Portola.”

The pharmaceutical companies expect to complete the clinical study in the second quarter of 2013.

In a related report, the Food and Drug Administration (FDA) recently approved Eliquis, a blood thinner developed by Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE), designed for patients with non-valvular atrial fibrillation, the common type of heart rhythm abnormality.

The main risk of blood thinners such as Xarelto, Eliquis, or Pradaxa is bleeding. Doctors use various ways to prevent the bleeding risks among patients taking anticoagulant medications. At present, there is no antidote for blood thinners.

Last June, the Cardiovascular and Renal Drugs Advisory Committee of the FDA voted against the proposal to add an indication for acute coronary syndrome in the label of Xarelto. The drug was approved in the United States to reduce the risk of blood clots in the legs and lungs of people who underwent a knee replacement surgery, hip replacement surgery, and to reduce the risk of hemorrhagic, thrombotic strokes, and blood clots among patients with atrial fibrillation not caused by a heart valve problem.