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Experts advise FDA approval of Simeprevir, a new hepatitis C drug
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There is new hope for safer and more effective treatment of patients suffering from genotype 1 Hepatitis C virus (HCV) infection. A group of government experts in the United States have recommended that the Food and Drug Administration (FDA) should approve simeprevir, an experimental hepatitis C drug from Johnson & Johnson which is taken as a simple daily pill. While the FDA is not obliged to follow the group’s recommendations, in practice it often does.

Simeprevir (TMC435), a second-generation protease inhibitor, follows in the footsteps first generation protease inhibitors such as telaprevir and boceprevir. These drugs, when administered with PEGylated interferon and ribavirin, have improved the cure rate for HCV. However, clinical trial data suggests that simeprevir is more easily used and has a lower adverse event incidence than the first-generation proteases, with no evidence of drug-drug interactions. Clinical trial data from Japan, for example, indicated that addition of simeprevir to a PEGylated interferon and ribavirin treatment regimen for drug-naïve HCV patients resulted in potent antiviral activity and a higher rate of sustained virologic response, while being generally safe and well tolerated. Simeprevir may be particularly beneficial in patients who have not responded positively to previous treatment. However, simeprevir still requires co-treatment with PEGylated interferon and ribavirin. Some individuals are interferon-intolerant. Therefore, future research aims should be to try to identify IFN-free regimens to treat HCV. The hope is that there may be potential to use simeprevir with other oral direct-acting agents without interferon.

A decision is expected from the FDA in about a month as to whether the recommendation to approve simprevir to treat HCV is accepted.

Sources

FLISIAK, R., JAROSZEWICZ, J. and PARFIENIUK-KOWERDA, A., 2013. Emerging treatments for hepatitis C. Expert Opinion On Emerging Drugs,

HAYASHI, N. et al., 2013. Once-daily simeprevir (TMC435) with peginterferon/ribavirin for treatment-naïve hepatitis C genotype 1-infected patients in Japan: the DRAGON study. Journal of gastroenterology,

YOU, D.M. and POCKROS, P.J., 2013. Simeprevir for the treatment of chronic hepatitis C. Expert opinion on pharmacotherapy

http://www.wboc.com/story/23782859/fda-a...tis-c-drug [Accessed 24 October 2013].
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Experts advise FDA approval of Simeprevir, a new hepatitis C drug00