FDA reviewers say data is ‘unconvincing’ to expand use of Forest Labs heart drug

Thursday, January 7, 2010

FDA staff against new use of Forest Labs drug

WASHINGTON — Federal health scientists said Thursday that Forest Laboratories’ hypertension drug should not be approved for a new use in patients at risk for heart failure.

In a review posted online, the Food and Drug Administration said results from a company study of Bystolic “lack robustness,” and don’t show a clear advantage for the drug.

New York-based Forest conducted a study called SENIORS which tracked 2,000 elderly patients at risk for heart failure who received either Bystolic or placebo.

The difference in cardiac death and hospitalization 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 span.

Researchers had originally planned on tracking patients for six months, but after the study was well under way they extended the follow-up period to 12 months.

But FDA reviewers said such changes only raise more questions about the drug’s effectiveness.

“Given these results and late changes to the trial, the totality of the evidence is not convincing to support a claim for treatment of heart failure,” the agency concludes.

A company spokeswoman could not immediately provide comment Thursday.

On Monday the FDA will ask an outside panel of heart experts to weigh in on whether Bystolic should be cleared for heart failure. The agency is not required to follow the group’s advice, though it usually does.

According to draft questions for the meeting, the FDA will ask its advisers whether Forest’s study — which was conducted abroad — is applicable to U.S. medical practice.

“We don’t have any U.S. data in this study, so we have no idea what the effect would be in the U.S.,” complains one FDA reviewer. Rates and severity of heart disease can vary from country to country based on medical practice, diet and social-economic factors.

Bystolic is a member of the beta blocker family of medications, which are used to treat high blood pressure, or hypertension. 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.

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