UPDATE 1-U.S. FDA panel rejects J&J drug for acute coronary syndrome

Thu Jan 16, 2014 5:32pm EST

By Toni Clarke

WASHINGTON Jan 16 (Reuters) - Johnson & Johnson's anticoagulant Xarelto should not be approved to prevent further heart problems in patients who have recently suffered a heart attack, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.

The panel voted 10 to 0, with one abstention, that data presented by the company from a single clinical trial was not strong enough to justify approval, especially since some data from was missing.

The FDA is not bound to follow the advice of its advisory panels but typically does so.

Xarelto is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems.

The company had hoped to also win approved for its use in patients with acute coronary syndrome (ACS), an umbrella term covering any condition brought on by a sudden, reduced blood flow to the heart, including heart attack and chest pain.

The vote follows a negative review from staff at the FDA whose report, published on Tuesday, noted that there was no proof the drug confers significant benefit.

Dr. Paul Burton, vice president of clinical development at Janssen Research and Development, a J&J unit, said in a statement that the company will "work with the FDA to address questions raised today."

J&J originally filed for approval of Xarelto in ACS at the end of 2011. The FDA rejected the application, citing missing data, and said the trial results were not strong enough to support approval. The company retrieved some missing data but the FDA once again declined to approve the drug, prompting J&J to appeal the decision.

The FDA denied the appeal but said limiting the duration of use to one month might be a pathway forward because efficacy was more evident and the risk of bleeding, a side effect of the drug, was lower during this period. J&J filed a new application seeking a treatment duration of 90 days.

Panelists said the inclusion of J&J's additional data did not alter their view that the benefit of the drug was not shown to outweigh an increased risk of bleeding.

Neither did they think it was possible to carve out a 90-day time frame from the overall clinical data and make definitive conclusions about the drug's safety or efficacy.

"Looking at the overall study it wasn't robust enough in terms of statistical significance to be considered a positive study, and with that it was not possible to look at subgroups," said Dr. Philip Sager, consulting professor of medicine at Stanford University School of Medicine.

Dr. Stephen Grant, deputy director of the FDA's division of cardiovascular and renal drugs, said the benefit of the drug met the criteria required to approve a drug based on a single trial - namely, proof it was superior in some way to existing products.

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