January 7, 2010 / 1:13 PM / 10 years ago

FDA staff against wider approval of Forest drug

WASHINGTON (Reuters) - A Forest Laboratories Inc hypertension drug should not be approved for people with heart failure, a U.S. drug reviewer said in a preliminary analysis released on Thursday.

The Food and Drug Administration staff memo, prepared for an agency advisory panel, said “the totality of evidence is not convincing to support a claim for treatment of heart failure” with the drug, Bystolic.

“Approval is not recommended” for the heart failure use, FDA reviewer Shona Pendse wrote, adding that “several critical changes” were made to the main study “that raise concerns as to the interpretability of findings.”

Safety data “does not reveal any specific causes for concern,” Pendse said.

Forest shares fell nearly 0.7 percent to $31.70 in early morning trading on the New York Stock Exchange.

Forest launched Bystolic in 2008 for treating high blood pressure. The drug’s second-quarter 2010 sales were $40.7 million.

An FDA panel of outside experts is scheduled to review data on the heart failure use at a public meeting on Monday. The panel will hear from FDA reviewers and the company before making recommendations.

Doctors are free to prescribe Bystolic now for treating heart failure, but Forest needs FDA clearance to promote the drug for that use. The FDA usually follows panel advice when making final approval decisions.

Chronic heart failure is a condition in which the heart cannot pump enough blood throughout the body, which can lead to tiredness, shortness of breath and other symptoms.

About 5 million people in the United States have heart failure, according to the National Institutes of Health. It contributes to about 300,000 deaths each year.

Bystolic, known generically as nebivolol, is part of the family of heart drugs known as beta blockers.

Forest’s main study tested Bystolic in heart failure patients age 70 and older to see if the drug reduced deaths or heart-related hospitalizations compared with a placebo. The company, in a separate summary released by the FDA, said Bystolic cut the risk by 14 percent.

Forest added that the trial tested people who were older and more like typical heart failure patients than in previous studies of other beta blockers.

The study “provides comprehensive and convincing evidence of clinical benefit in a study population that more closely matches U.S. patients with heart failure,” Forest said. The study was conducted in Europe.

Forest spokesman Frank Murdolo said the company had no comment on the FDA documents.

The FDA posted the staff and company summaries here

Reporting by Lisa Richwine, editing by Dave Zimmerman

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