Regulatory

US FDA sees safety issue with investigational Merck hepatitis drug

Last Updated: 2011-04-25 17:51:08 -0400 (Reuters Health)

By Lisa Richwine

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 drug, boceprevir, at a public meeting on Wednesday. FDA staff said they generally agreed with Merck's assessment that boceprevir is effective in treating hepatitis C, a viral disease that destroys the liver.

A main issue for discussion is an increase in anemia, 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.

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.

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.