FDA Panel Rejects Forest's Bystolic For Heart Failure
January 11 2010 - 4:28PM
Dow Jones News
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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