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The panel of the Food and Drug Administration (FDA) voted unanimously against approving Bystolic to prevent death or the need for hospital treatment caused by heart failure.
The outside panel of heart specialists voted 8-0 against New York-based Forest Laboratories’ new use of the drug.
Forest markets Bystolic to treat hypertension, or high blood pressure. An extra approval for heart failure would potentially expand the drug’s market to around 5.7 million US patients with the disease.
Forest tracked 2,000 elderly patients at risk of heart failure who received either Bystolic or a dummy pill. But the difference in cardiac death and hospital admissions due to heart failure between the two groups was not statistically significant, said the FDA.
Reviewers from the administration said Forest made major adjustments to the design of the trial over its four-year timespan.
The FDA does not have to follow the advice of the group, although it usually does.
Bystolic is a member of the beta blocker family of medications. Competing drugs in the class include generic versions of AstraZeneca’s Toprol and GlaxoSmithKline’s Coreg.
Copyright Press Association 2010
