Bayer Announces Updates to European Label of Xarelto

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Bayer (BAYRY) announced that the label for its anticoagulant drug Xarelto will now include specific guidance for doctors treating patients with non-valvular atrial fibrillation (AF) undergoing cardioversion in Europe.

The updated label will provide physicians with important information on the clinical utility of Xarelto in patients with AF who require cardioversion. The label update was based on a positive opinion from the Committee for Medicinal Products for Human Use issued last month.

We note that Xarelto is jointly developed by Bayer and Janssen Pharmaceuticals, Inc., a Johnson & Johnson (JNJ) company. The drug is marketed by Johnson & Johnson in the U.S. and by Bayer outside the U.S. Xarelto is approved for several indications including stroke prevention in non-valvular atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE) and reduction of the risk of recurrent DVT and PE. The product is also approved for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an acute coronary syndrome.

Our Take

We are pleased with the Xarelto label update. Xarelto has put in an impressive performance since its launch. The drug, an important one at Bayer’s newly approved drugs portfolio, contributed €1.163 billion in the first nine months of 2014. Further label expansion of the drug will boost sales.

Bayer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. (AMAG) and Impax Laboratories Inc. (IPXL). While Impax Labs carries a Zacks Rank #1 (Strong Buy), AMAG holds a Zacks Rank #2 (Buy).

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