FDA Reviewer Backs Expanded Approval Of Bayer, J&J's Xarelto
05/21/2012| 11:31am US/Eastern
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(Updates with additional information starting in fifth paragraph including recommended Xarelto warnings.)
--FDA reviewer backs expanded approval of Xarelto; cautions on bleeding risks
--Xarelto anticlotting drug faces FDA panel review on Wednesday
By Jennifer Corbett Dooren
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A Food and Drug Administration medical reviewer recommended the agency expand the approval of Johnson & Johnson's (JNJ) and Bayer AG's (BAYRY, BAYN.XE) anticlotting drug Xarelto to treat patients with a heart problem known as acute coronary syndrome.
Xarelto, considered part of a new generation of blood-thinning drugs, was approved last year to prevent strokes in patients with a heart rhythm disorder called atrial fibrillation and is also approved for short-term use in patients undergoing knee- or hip-replacement surgery.
The companies are now seeking approval to market Xarelto for use in treating acute coronary syndrome, which occurs when a blood clot develops inside a coronary artery and reduces blood flow to the heart. As part of that process, Xarelto will be reviewed on Wednesday by an FDA advisory panel.
The panel, which is made up of non-FDA medical experts, is being asked vote on whether it thinks Xarelto should be approved and to discuss several issues including whether the drug should carry the agency's most stringent boxed warning discussing bleeding risks.
The FDA released its review of Xarelto in preparation for Wednesday's meeting. One of the agency's medical reviewers recommended Xarelto's approval to "reduce the risk of cardiovascular events in patients with acute coronary syndrome."
However, the same medical reviewer also said the drug shouldn't be used in patients with a prior history of stroke and recommended a boxed warning be placed on Xarelto to warn of bleeding risks in certain patient groups. Still, the reviewer's recommendation increases the chances that the advisory panel will also recommend approval of Xarelto for more patients.
The main clinical study submitted by the companies involved more than 15,000 patients who were hospitalized with acute coronary syndrome. Patients were randomized to be treated with one of two doses of Xarelto or a placebo medicine. All patients received other medicines used to treat ACS including low-dose aspirin and Plavix.
On average, patients were followed for 13 months. Overall, the study found patients in the Xarelto group had a 16% reduction in the risk of combination of cardiovascular death, stroke or a heart attack compared with those who didn't receive the medicine.
The FDA said the benefit was mostly been among the lower, 2.5 milligram dose of the drug, which is the dose the companies are asking for agency approval to use in patients with ACS. FDA reviewers said the benefit of Xarelto was driven by a reduction in heart-related deaths. However, there was also an increased risk of bleeding, including fatal bleeding, FDA said. However, the agency said the reduction in heart-related deaths outweighed the bleeding risks.
In a background document prepared for the meeting, J&J said although bleeding-related strokes were higher among Xarelto-treated patients that fatal bleeding rates were similar. Six patients out of 5,115 who received 2.5 milligrams of Xarelto compared with nine patients out of 5,125 who didn't received the drug died from a bleeding-related complication.
While FDA's Xarelto review was generally positive, the agency said it was concerned about missing data in the study including 1,000 patients who were listed as having "unknown vital status" at the end of the study. About 2,400 patients, or 15%, stopped participating in the study prematurely.
Xarelto competes with a similar drug, Pradaxa, from Boehringer Ingelheim GmbH as an alternative to warfarin, an older blood thinner. Another blood-thinning drug, Eliquis by Bristol-Myers Squibb Co. (>> Bristol Myers Squibb Co.) and Pfizer Inc. (PFE) is approved for short-term use in Europe. The companies are hoping for FDA approval to market Eliquis as a stroke-prevention treatment in atrial-fibrillation patients in the U.S by the end of June.
-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com
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