FDA approves Johnson & Johnson, Bayer’s Xarelto for DVT

The FDA on Friday approved Johnson & Johnson and Bayer’s Xarelto (rivaroxaban) for the prevention of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery. Bayer noted that Xarelto is the only new oral anticoagulant approved in the US for venous thromboembolism prophylaxis for patients undergoing knee or hip replacement surgery.

The approval was based on late-stage data that showed Xarelto was more effective in both a head-to-head comparison with sanofi-aventis' Lovenox (enoxaparin) and when compared to enoxaparin followed by placebo. In the trials, Xarelto demonstrated a similar safety profile to enoxaparin, including lower rates of major bleeding.

The companies in January submitted regulatory filings in Europe and the US seeking approval of Xarelto for the prevention of stroke in patients with atrial fibrillation. Johnson & Johnson’s head of cardiovascular research Martin Fitchet noted that US regulators will probably announce a decision on the drug in this indication by the end of 2011, with a similar timeline expected for a decision in the EU. Bayer, which markets the drug in Europe and will lend sales support in the US, has forecast that Xarelto will generate more than 2 billion euros ($2.9 billion) in annual sales if it is approved for use in AF.

Citigroup analyst Matthew Dodds noted that Johnson & Johnson has been “waiting for a blockbuster” in the cardiovascular drug market and Xarelto “is widely viewed as that product.” He predicted that the drug may generate as much as $1.6 billion in annual sales, of which $1.2 billion would be in the atrial fibrillation indication.

Xarelto is the second oral anticoagulant approved by the FDA within the last nine months. In October, US regulators approved Boehringer Ingelheim’s Pradaxa (dabigatran) for the prevention of stroke in patients with AF. In addition, Pfizer and Bristol-Myers Squibb recently reported positive results from late-stage clinical trials of its Eliquis (apixaban) in AF and the companies are expected to file for regulatory approval of the drug by the end of this year.

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