Wednesday, April 16, 2014
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Update: FDA panel votes against approving Johnson & Johnson blood thinner Xarelto

Late Wednesday afternoon, an FDA panel voted 6-4 against recommending approval of the Johnson & Johnson blood thinning drug Xarelto for use in reducing blood clots.

Update: FDA panel votes against approving Johnson & Johnson blood thinner Xarelto

UPDATE: Late Wednesday afternoon, an FDA panel voted 6-4 against recommending approval of the Johnson & Johnson blood thinning drug Xarelto for use in reducing blood clots.

As mentioned here earlier today, the panel was asked to wrestle with concerns that the drug caused fatal internal bleeding in too many patients in clinical trials and that too many participants dropped out of the trials without J&J figuring out what happened to them.

According to the Associated Press report from the hearing in Silver Spring, Md., the panel decided those concerns were too great to approve the application. The FDA does not have to follow panel votes, but usually does.

The drug is already available for other conditions, but approval would have expanded the market for J&J and its subsidiary, Janssen Pharmaceuticals.

From Wednesday morning:

The U.S. Food and Drug Administration's cardiovascular and renal drugs advisory committee will meet Wednesday to review whether the drug, rivaroxaban (brand name Xarelto) should be approved as a blood thinner to help patients with heart disease avoid blood clots, which can cause heart attacks and strokes.

The drug is made by Johnson & Johnson's subsidiary Janssen Pharmaceuticals, but J&J has a marketing deal with Bayer AG.

This application and hearing is to decide on whether the label - and advertising and promotion - can say Xarelto works as an anticoagulant. The FDA approved Xarelto last November to prevent stroke in patients with irregular heartbeat and Bloomberg noted that it is already prescribed for patients undergoing some joint replacement surgery.

The briefing materials were released Monday in advance of the meeting and the reviewer, Dr. Karen A. Hicks, said she would recommend approval, but with several concerns.

Among the first concerns is that a batch of patients in the trials died from internal bleeding. Another concern was that a batch of patients - 15 percent - in the trials dropped out before the study was complete and Janssen didn't adequately figure out why and what happened to enough of them.

"Please discuss how the quality of a study, the missing follow-up and other data problems, should be factored into the interpretation of study results," Hicks said in her report to the committee, though she noted that it is a common problem in studies of this sort.

The panel is likely to vote and the FDA usually follows the decision of advisory committees, but it does not have to. A final decision might arrive by the end of June.

The AP reported that Wells Fargo analyst Larry Biegelsen said he expects "a very heated debate" over Xarelto's safety at the panel meeting, but concluding with a positive panel vote.

The FDA briefing document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is here.

The Bloomberg story is here.

The Wall Street Journal story is here.

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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