FDA Panel Rejects Forest's Bystolic For Heart Failure

A federal advisory panel recommended against approving Forest Laboratories Inc.'s (FRX) blood-pressure drug Bystolic for use to treat heart-failure patients.

The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee unanimously voted against a question that asked if the product should be approved "in any heart failure population to reduce mortality and cardiovascular hospitalization."

The vote follows an FDA staff review which said study results involving Bystolic weren't strong enough to merit approval. The FDA usually follows the advice of its outside panels of medical experts but is not required to.

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, but given the panel decision on top of the negative staff review it's unlikely Bystolic will be approved to treat heart-failure patients.

In background materials prepared for the panel meeting, 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 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 who were treated for about 19 months. About half of the patients received Bystolic while the other half received a placebo, or inactive treatment.

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

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