FDA Says Highly Anticipated Merck Drug Eliminated Traces of Hepatitis C

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FDA Says Highly Anticipated Merck Drug Eliminated Traces of Hepatitis C

From the PharmaLive.com News Archive - Apr. 25, 2011

From BioMed Reports (April 25, 2011)

Federal health officials say a highly-anticipated drug to treat hepatitis C made

by Merck appears to cure more patients in less time than established drugs that

have been used for 20 years. But the agency has questions about how the drug

should be combined with older medicines for the maximum effect.

The Food and Drug Administration posted its review of Merck & Co. Inc.'s

boceprevir ahead of a public meeting next week to consider whether to approve

the medication. The meeting brings to a head more than 15 years of research to

find a better therapy for a virus that infects about 3.2 million people in the

U.S.

Food and Drug Administration staff said in a summary prepared for an advisory

panel that will review the drug on Wednesday.

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.

FDA staff said they generally agreed with Merck's assessment that boceprevir was

effective in treating hepatitis C, a disease that destroys the liver. Analysts

project the drug could generate blockbuster sales if approved. FDA scientists

said the two studies submitted by Merck showed patients had undetectable virus

levels six months after completing treatment with boceprevir.

* FDA Panel Is Set To Review Two New Hepatitis C Drugs - Wall Street Journal

(news.google.com)

* Hepatitis C drugs could cure disease - Shreveport Times (news.google.com)

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