Advisory Panel Recommends Against Anticoagulant Drug Approval

On May 23, 2012, an FDA advisory panel narrowly recommended against expanding the use of the Johnson & Johnson drug Xarelto on Wednesday, citing concerns that bleeding outweighed evidence that the drug helped reduce the risk of blood clots in patients with serious heart problems.  Xarelto is an anticoagulant drug that was approved in 2011 to prevent blood clots in patients undergoing knee or hip replacement surgery and for people with atrial fibrillation.  Johnson & Johnson is seeking to expand the use of the drug to patients with acute coronary syndrome (ACS).  Current treatments for the condition include use of aspirin plus clopidogrel (Plavix).

Several members of the advisory panel were concerned about the idea of adding a third drug to the standard treatments, and said the benefits of doing so did not outweigh the risks.  More than 15 percent of the study’s participants had dropped out, calling into the question the breadth of the data acquired.  As reported in the media, in a clinical trial of ACS, people who took a 2.5 milligram dose of Xarelto in addition to an aspirin and another anti-platelet medication had a 15 percent lower risk of having a stroke or dying from a heart attack than people just taking the other medicines.  However, the patients taking Xarelto had twice as much risk for a major fatal bleeding compared to the older drugs, while other kinds of bleeding were three times higher with Xarelto.  The overall rates were still low – only 0.1 percent of patients had fatal bleeding while taking the drug and 2 percent had some kind of bleeding.

Xarelto would join a slate of other drugs that prevent strokes and other dangerous conditions caused by blood clots, in a market worth up to $10 billion in annual sales, according to Wall Street forecasts.  Investors have tried to bet on which of the three will become the dominant player in a race between Xarelto, Eliquis from Pfizer Inc and Bristol-Myers Squibb Co, and Boehringer Ingelheim’s Pradaxa.

Xarelto’s rivals failed in treating patients with ACS, giving Johnson & Johnson a potentially distinct market – although stroke prevention in atrial fibrillation is seen as the most lucrative use for the new drugs.