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FDA rejects new use for Forest heart drug

Advisers to the US FDA have unanimously rejected an attempt by Forest to expand hypertension drug, Bysotolic, to cover heart failure

Advisers to the US Food and Drug Administration (FDA) have unanimously rejected an attempt by Forest Laboratories to expand its hypertension beta blocker, Bysotolic, to cover heart failure.

The FDA will make a final decision concerning the use of Bysotolic on March 1.

The Cardiovascular and Renal Drugs Advisory Committee voted 8-0 against a question that asked if the product should be approved "in any heart failure population to reduce mortality and cardiovascular hospitalisation".

The news follows documents released last week where FDA reviewers said that Bysotolic's new use lacked 'robustness' and that there was no clear advantage for the drug.

Forest, a New York based company specialising in therapeutic areas of the central nervous and cardiovascular systems, had submitted a study involving over 2,000 elderly patients who were at risk for heart failure.

The review body however saw no significant difference in the reduction of death and heart failure related hospitalisations between those half treated with Bysotolic and those given a placebo over the 19-month test period.

There were also concerns from the panel about alterations made during the trial's total four-year timespan.

"Several critical changes were made late in the study that raise concerns as to the interpretability of the findings," stated the review. "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."

Bysotolic, currently used to help lower dangerously high blood pressure, was launched in 2008 with Forest reporting $69.2m in Bysotolic sales for fiscal 2009. An approval for heart failure would potentially expand the drug's market to roughly 5.7m US patients with the disease.

 

 

12th January 2010

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