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J&J seeks OK for new use for anticlotting drug

By Linda A. Johnson

Associated Press

Published: Thursday, Dec. 29 2011 11:25 a.m. MST

TRENTON, N.J. — Health care giant Johnson & Johnson is seeking U.S. approval for a third use for its new anticlotting pill, Xarelto.

The company's Janssen Research & Development LLC unit said Thursday that it has asked the Food and Drug Administration to approve the clot-preventing drug for patients with acute coronary syndrome. That's a condition in which narrowing or blockage of a blood vessel suddenly reduces blood flow to the heart muscle, causing unstable chest pain or a heart attack.

Xarelto, known chemically as rivaroxaban, was approved eight weeks ago for use in patients who have an irregular heartbeat called atrial fibrillation not caused by a heart valve problem. More than 2 million Americans have the condition, in which the heart's upper chambers flutter chaotically, reducing blood flow through the heart and increasing the risk of clots and stroke.

Xarelto was first approved in July, for preventing dangerous blood clots in patients undergoing hip or knee replacement surgery. It works by blocking a clotting protein called Factor Xa.

J&J developed Xarelto jointly with Bayer HealthCare. Johnson & Johnson has the U.S. marketing rights; Bayer will sell it in other countries.

The drug is part of a new class of anticlotting medicines bringing doctors and patients a long-sought alternative to the standard blood thinner warfarin, which works by preventing blood platelets from clumping together.

Warfarin, also sold under brands such as Coumadin, is an inexpensive generic drug, but it interacts with food and patients need frequent blood tests and doctor visits to make sure the dosing is correct. Too little can lead to life-threatening blood clots, and too much can result in dangerous internal bleeding.

The newer drugs could become blockbusters because so many millions of people around the world are at risk for dangerous blood clots. But they are pricey, costing more than 10 times the 50-cent-a-day price of warfarin, so the key will be how readily insurers cover their cost.

The FDA, after analyzing patient testing data for Xarelto, turned down a request by J&J and Bayer to let them claim it's superior to warfarin at preventing strokes and blood clots. Instead the companies can only say it works about the same.

The first new anticlotting drug, Pradaxa from German drugmaker Boehringer Ingelheim GmbH, was approved in October 2010 for patients with atrial fibrillation. Also called dabigatran, it inhibits an enzyme called thrombin that's essential for clot formation.

Meanwhile, partners Bristol-Myers Squibb Co. and Pfizer Inc. four weeks ago applied for FDA approval of their Eliquis for preventing strokes and blood clots in atrial fibrillation patients. The drug is getting a priority review, with a target date of March 28 for a decision, according to the companies.

Eliquis, also called apixaban, was approved in the 27 European Union countries in May for preventing blood clots in patients getting hip or knee replacement surgery.

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