The Food and Drug Administration has agreed to give priority status to its review of three new uses for the anticlotting drug Xarelto, Johnson & Johnson announced Monday.
The company is asking the agency to approve the drug to treat deep vein thrombosis and pulmonary embolism, and to prevent recurrence of both conditions. Under priority reviews, the F.D.A. tries to reach a decision in six months instead of the usual 10.
An estimated 900,000 people are stricken by deep vein thrombosis — a blood clot in a large, deep vein, such as a leg vein — or by pulmonary embolism, which occurs when one of those clots dislodges and travels to the lung. One third of those cases result in death, the company said.
“If approved for these indications, Xarelto has the potential to address critical unmet needs in treating patients with these serious medical conditions,” Dr. Paul Burton, vice president of the cardiovascular franchise at Janssen Research & Development, a unit of Johnson & Johnson, said in a statement.
The applications reflect the effort by pharmaceutical companies to compensate for the loss of revenue from best-selling drugs that have lost patent protection in recent years. One popular strategy is to squeeze as many uses as possible out of drugs that still have patent exclusivity.
Xarelto was approved in 2011 for two uses: to prevent blood clots in patients undergoing knee or hip replacement surgery and for people with a common form of heart arrhythmia known as atrial fibrillation. But efforts to expand the use of Xarelto have not been successful. In June, the F.D.A. turned down Janssen’s application to use Xarelto to help reduce the risk of heart attack and stroke in patients with a condition called acute coronary syndrome.
The decision was a blow to Johnson & Johnson and Bayer, which are developing the drug together. Approval could have helped the companies increase sales significantly by marketing to the estimated 1.2 million people who are discharged from hospitals each year with a diagnosis of acute coronary syndrome, a sudden loss of blood to the heart. An advisory panel in May concluded that concerns over dangerous bleeding outweighed the benefits in patients with the condition.
Because of that decision, Janssen officials also announced Monday that they would withdraw an application for another new use, one that would have reduced the risk of clots that form on stents. Coronary stents, intended to keep arteries open after blockages have been cleared, are implanted in about 1.5 million patients a year, Janssen said.
Xarelto and Pradaxa are part of a new class of anticoagulant drugs that are intended to replace warfarin, the current treatment standard for millions of people with atrial fibrillation. Warfarin is much less expensive than the new drugs but requires careful monitoring to avoid dangerous side effects.
Xarelto has trailed Pradaxa in sales, bringing in $29 million in the first quarter of this year, compared to Pradaxa, which tallied $209 million, according to IMS Health, a consulting firm.
Bristol-Myers Squibb and Pfizer are seeking approval for a third drug in the group, to be called Eliquis. But the F.D.A. has twice delayed making a decision on the drug, most recently in June, when it asked the companies for more information about its trial data.
http://www.nytimes.com/2012/07/10/health/fda-expedites-review-of-new-uses-for-xarelto-an-anticlotting-drug.html?partner=rss&emc=rss
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