FDA experts unanimously oppose new heart failure indication for Forest Labs drug

Monday, January 11, 2010

FDA panel rejects new use for Forest heart drug

WASHINGTON — Federal health advisers on Monday unanimously rejected a new use of Forest Laboratories’ hypertension drug for patients at risk of heart failure.

The Food and Drug Administration’s outside panel of heart specialists voted 8-0 against approving Bystolic to prevent death or hospitalization caused by heart failure, according to an agency spokeswoman.

The FDA is not required to follow the group’s advice, though it usually does.

Forest already markets Bystolic to treat hypertension, or high blood pressure. An additional approval for heart failure would potentially expand the drug’s market to roughly 5.7 million U.S. patients with the disease.

FDA reviewers said in documents issued last week that company data on the new use for Bystolic “lack robustness,” and don’t show a clear advantage for the drug.

New York-based Forest tracked 2,000 elderly patients at risk for heart failure who received either Bystolic or a dummy pill.

The difference in cardiac death and hospitalization due to heart failure between the groups was not statistically significant, according to the FDA.

Agency reviewers also complained that the company made major adjustments to the design of the trial over the course of its four-year timespan.

The FDA also raised questions about whether Forest’s study — which was conducted abroad — was applicable to U.S. medical practice.

Bystolic is a member of the beta blocker family of medications, which are used to help lower dangerously high blood pressure. Forest reported $69.2 million in Bystolic sales for fiscal 2009, according to the company’s annual report.

Competing drugs in the class include generic versions of AstraZeneca’s Toprol and GlaxoSmithKline’s Coreg.

Beta blockers were the fifth most commonly prescribed drug in the U.S. during 2008, with 130 million prescriptions, according to health care research firm IMS Health.

Shares of Forest Laboratories rose 36 cents to close at $31.40 on Monday.

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