Blood-Pressure Drug Bystolic Should be Denied Broader Approval, FDA Staffers Say

The Food and Drug Administration should refuse to approve the blood-pressure drug Bystolic for treating some heart-failure patients, agency staffers say.

Forest Laboratories Inc. has asked the FDA to approve Bystolic for use in certain patients with heart failure, a condition in which the heart is no longer able to pump blood through the body. The generic form of Bystolic is called nebivolol, according to a report in The Wall Street Journal.

Bystolic was FDA approved in 2007 for treating people with high blood pressure. Forest Labs is now seeking to market the drug for more patients.

An FDA advisory panel is set next week to consider Forest Labs’ request for Bystolic and make a recommendation to the FDA, which the agency may or may not follow. However, FDA staff members have already made known their feelings about additional approvals for the drug.

Questions Surround Bystolic Trial

A staff review document concluded that questions about the findings from a clinical study of Bystolic in more than 2,000 heart failure patients mean the safety of using the drug is in doubt.

“Several critical changes were made late in the study that raise concerns as to the interpretability of the findings,” the review said, according to the Journal. “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 Labs is defending the Bystolic study and said the findings demonstrate statistically significant improvement in reducing death and heart-related hospitalizations. The placebo-based study involved 2,135 patients with an average age of 76 years who were treated for about 19 months, the Journal reports.

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