Reuters: Regulatory News: UPDATE 1-Missing data raise doubts on J&J drug-US FDA staff

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UPDATE 1-Missing data raise doubts on J&J drug-US FDA staff May 21st 2012, 13:21 Mon May 21, 2012 9:21am EDT WASHINGTON May 21 (Reuters) - U.S. drug reviewers said missing data for Johnson & Johnson's blood thinner Xarelto raised doubts about whether the drug actually reduced the risk of new heart attacks and strokes in people with heart problems. The U.S. Food and Drug Administration staff also said it was doubtful the pill reduced the risk of death in patients with acute coronary syndrome, which analysts had seen as the drug's most important advantage for treating this heart condition. An FDA advisory panel of outside experts will vote Wednesday on whether to recommend the drug. The FDA usually follows panel recommendations, although it is not required to. The agency is due to make a final decision on Xarelto by the end of June. Xarelto, which J&J developed in partnership with German drugmaker Bayer AG, is already approved to reduce the risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery. It is also approved to prevent strokes among people with irregular heartbeats, called atrial fibrillation. The companies are hoping to get Xarelto approved for a third use: reducing the risk of stroke and heart attack in people with acute coronary syndrome (ACS). ACS is an umbrella term that refers to people who have heart attacks or chest pain usually caused by a blocked coronary artery. About a million people in the United States are hospitalized each year after having an ACS episode, usually a heart attack, according to researchers. Xarelto is one of three new medicines that offer potential advantages over older drugs to 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. Link this Share this Digg this Email Reprints

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