FDA Says Highly Anticipated Merck Drug Eliminated Traces of Hepatitis C
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.
2010 BioMed Reports All rights reserved.
Posted: April 2011