FDA Review Recommends Against Forest Drug For Heart Failure

A Food and Drug Administration staff review recommended against approving Forest Laboratories Inc.'s (FRX) blood-pressure drug Bystolic for use to treat heart-failure patients.

Bystolic was approved in 2007 to treat high blood pressure. The company is seeking wider approval to market the drug to treat certain patients with heart failure.

Bystolic is scheduled for a review Monday by an outside panel of medical experts who are being asked to vote on whether it thinks the indication for the product should be widened.

However, in background materials posted to the FDA's Web site Thursday, an agency medical reviewer recommended that nebivolol, the generic name for Bystolic, not be approved for use in treating heart-failure patients.

The reviewer said there were too many changes made during a study that involved more than 2,000 patients with heart failure.

"Several critical changes were made late in the study that raise concerns as to the interpretability of the findings," the review said. "Given these results and the late changes to the trial, the totality of the evidence is not convincing to support a claim for treatment of heart failure."

Forest, in a document also posted on the FDA's Web site, said the study did reach its goal of having a statistically significant improvement in reducing death and heart-related hospitalizations. The study involved 2,135 patients with an average age of 76 years who were treated for about 19 months. About half of the patients received Bystolic while the other half received a placebo, or inactive treatment.

Forest is down 1.6% to $31.41 in recent premarket action.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294.

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