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.
|Separate and Unequal Access Frames Discussion at CROI Panel on U.S. HIV Care Cascade|
|CROI 2018: Highlights and What's Next for Advocates|
|Reported PrEP 'Failure' Most Likely a Lack of Proper Testing and Adherence|
|Injection Drug Use Among People Living With HIV: A Missed Opportunity to Save Lives|
|Statin Use Might Reduce Risk of Cancer in HIV-Positive People|
|Insurers and Pharmas Must Help Fix HIV Drug Pricing System, Advocates Say|