[mtwalsh01]

Previously on this forum we reported that a group of experts had recommended FDA approval of the Johnson and Johnson experimental Hepatitis C drug simeprevir (http://www.biotechnologyforums.com/thread-2564.html). At that time we noted that while the FDA is not obliged to follow the group’s recommendations, in practice it often does. We can confirm that last Friday the FDA gave approval to Johnson and Johnson and its partner Medivir to market simeprevir, which will be sold under the name of Olysio.

Simeprevir is a second generation protease inhibitor which has been developed as part of the research community’s response to the need to develop Hepatitis C drugs that have reduced or no need for co-treatment with interferon. While simeprevir still requires co-administration of PEGylated interferon and ribavirin, it is in reduced amounts compared to the current protease inhibitors on the market, i.e. Incivek (Vertex) and Victrelis (Merck). Phase III trial data suggests that simeprevir may be particularly beneficial in patients who have not responded positively to previous treatment. It is also easily administered as a simple daily pill and is safe and well-tolerated while delivering a sustained virological response.

However, research efforts in this field are intense and simeprevir may find itself in competition relatively soon with drugs such as Enanta’s lead protease inhibitor ABT-450 which recently delivered positive phase III data in difficult-to-treat Hepatitis C patients in a pegylated interferon-free regimen, as we recently reported (http://www.biotechnologyforums.com/thread-2637.html). The intensity of the work in this field can only be of benefit to Hepatitis C patients.

Sources

http://www.fiercebiotech.com/story/jj-me...2013-11-25 [Accessed 25 November 2013].

http://www.fiercebiotech.com/press-relea...is-c-virus [Accessed 25 November 2013].

http://www.biospace.com/News/abbvie-enan...s-c/316030 [Accessed 19 November 2013].

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

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, 2013

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

http://www.wboc.com/story/23782859/fda-a...tis-c-drug