FDA sees safety issue with Merck hepatitis drug

WASHINGTON Mon Apr 25, 2011 12:02pm EDT

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WASHINGTON (Reuters) - U.S. drug reviewers highlighted safety issues with an experimental Merck & Co hepatitis drug, including anemia and reports of psychiatric problems, in documents released on Monday.

A Food and Drug Administration advisory panel will review the potential blockbuster drug, boceprevir, at a public meeting on Wednesday. FDA staff said they generally agreed with Merck's assessment that boceprevir was effective in treating hepatitis C, a disease that destroys the liver.

A main issue for discussion is an increase in anemia, a deficiency of red blood cells, FDA reviewers said in a preliminary analysis prepared for the panel.

Another "potential safety signal" is a higher number of patients who reported psychiatric symptoms such as suicidal and homicidal thoughts, the FDA reviewers said. But they added it was "difficult to make any meaningful clinical conclusions" about the cases. The same symptoms have been reported with pegylated interferon, one of the hepatitis treatments also given to patients in the Merck studies, FDA staff said.

J.P. Morgan analyst Geoff Meacham said the staff comments were "in line with expectations" and supported a positive recommendation for approval. The focus on anemia was expected and the issue "doesn't look to be a deal-breaker," Meacham said in a research note.

He said the psychiatric issue was new but noted those symptoms already were linked with the other hepatitis treatment.

Merck shares were up 2 cents at $34.06 on Monday morning on the New York Stock Exchange.

Boceprevir and a proposed drug from Vertex Pharmaceuticals Inc are considered possible blockbuster products because of their potential to cure far more patients and in as little as half the time of standard drugs. Current therapies require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate.

The FDA is set to release its preliminary analysis of the Vertex drug, telaprevir, on Tuesday and an advisory panel will review the medicine on Thursday.

Merck, in a separate summary released by the FDA, said boceprevir would help fulfill a need for more effective hepatitis C treatments. "The benefits of boceprevir outweigh the risks," the company said.

(Reporting by Lisa Richwine, editing by Gerald E. McCormick and Matthew Lewis)

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