January 11, 2011
The U.S. Food and Drug Administration (FDA) has granted an accelerated review of Merck & Co.'s experimental hepatitis C drug boceprevir, a status designated for drugs that represent a significant medical advancement or address a public health need.
Merck said it submitted boceprevir's application to U.S. and EU regulators last year. FDA generally aims to complete reviews of priority applications within six months, compared with the standard 10-month review period.
Another hepatitis C drug, developed by Vertex Pharmaceuticals Inc. and Johnson & Johnson, is also in the pipeline. In December, J&J said the European Medicines Agency had granted an expedited review of telaprevir. However, Vertex, which is handling the FDA application, has not announced a priority review in the United States.
Both drugs are protease inhibitors, which block an enzyme that allows hepatitis C to replicate. While it has been noted that telaprevir has been more effective in clinical trials in curing the infection compared to boceprevir, the two have not been tested head-to-head in the same study.
Standard hepatitis C treatment involves a combination of pegylated interferon and ribavirin. It is hoped that protease inhibitors will boost cure rates, potentially shortening treatment.
Wall Street Journal
01.06.2011; Peter Loftus
No comments have been made.
The content on this page is free of advertiser influence and was produced by our editorial team. See our content and advertising policies.
|CDC Corrects Misleading HIV Conception Guidance, Responding to Community Pressure|
|This Week in HIV Research: Injectable PrEP Shows Promise in New Study|
|New York Study Finds Almost Half of HIV-Positive Gay Men Co-Infected With Hepatitis C Have Detectable Levels of Hepatitis C Virus in Their Rectal Fluid|
|This Week in HIV Research: A New Glimpse Into HAND|
|This Week in HIV Research: New Discovery in How HIV Hijacks a Cell|
|Research in New York Confirms That MSM Will Likely Follow Up After a Positive at-Home HIV Test|