Johnson & Johnson has been denied Food and Drug Administration approval of its blood thinner drug, Xarelto, as a treatment for the heart condition, acute coronary syndrome (ACS).
This was the second time the drug has been rejected for that use by the agency. German drugmaker Bayer AG markets the product overseas while Johnson & Johnson markets it in the U.S. where it’s one of several new drugs that offer an alternative to warfarin (Coumadin).
Coumadin is the standard blood thinner that’s been prescribed for more than 50 years but requires the patient to undergo regular blood monitoring. Pradaxa is among the new alternatives to warfarin but it too has problems such as no reversal agent like vitamin K used with warfarin to stop a bleed out.
The problem with Xarelto is an increased risk for bleeding. A published trial of 14,000 patients comparing Xarelto to warfarin found the risk of major bleeding was similar however Xarelto caused more bleeding in the stomach and intestines and less in the brain.
When giving Xarelto in addition to statins and Plavix, the risk of a heart attack or death was reduced by 16% but the quadruple risk of bleeding eclipsed the benefit.
Last June an FDA panel denied the use of Xarelto because of the bleeding risks and missing trial data.
Xarelto is approved for use in patients following hip and knee replacement surgery to prevent blood clots. In November 2011, the FDA approved Xarelto as a stroke prevention treatment in people with non-valvular atrial fibrillation.
More than two million Americans suffer from this type of abnormal heart rhythm where the heart beat is irregular and not coordinated in the two upper chambers of the heart. The condition can cause blood to pool in the chambers and can result in blood clots. Non-valvular atrial fibrillation refers to patients who do not have a problem with their heart valves.
Other drugs approved by the FDA to reduce blood clots include Lovenox, the generic enoxaparin, Arixtra, Fragmin and heparin.
Johnson & Johnson and Bayer AG stand by their product and are reviewing the latest rejection letter.