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Priority Review Granted to Hep C Drug Simeprevir

May 15, 2013

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Due to positive results from three Phase III trials, the FDA has granted a priority review to simeprevir, a Hepatitis C protease inhibitor that is administered with interferon and ribavirin therapy.

Simeprevir Given Priority Review Status By FDA For Hepatitis C Treatment

With stunning results in Phase III clinical trials, the hepatitis C drug is now on a fast track for FDA approval.

By Jonathan Weiss | May 13, 2013

Following previous hepatitis C treatments that were given expedited U.S. Food and Drug Administration (FDA) approval processes and breakthrough status designations, Janssen and Medivir’s jointly developed simeprevir has been given priority review status by the FDA, Medivir announced today. Priority reviews have historically reduced the approval process time by half and are given to drugs that have evidence of increased effectiveness, prevention, or diagnoses of a disease.

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http://www.medicaldaily.com/articles/15454/20130513/simeprevir-fda-hepatitis-c-hepatitis-c-drug.htm

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  • Brian Dusel

    Just another Interferon based treatment! And since this is another protease inhibitor this treatment is useless for those that tried and failed the hugely disappointing & over rated Incivek.

    • zenseekercu

      Yes, I followed the required treatment for Incivek to a ‘T’. I showed an initial response (which I also did with Pegasys and Ribavirin before), but relapsed as soon as I discontinued the drugs. I’m holding out for an all-oral therapy, if I live that long. The FDA can be pretty slow. I am type 1.

      • Wil James

        I am type 1 also. I did the combination therapy, pegasys and ribiviran. Relapsed as soon as I finished treatment. I also did pegasys by its self. Same result. Is there anything in the wings?

        • zenseekercu

          Sorry to be so long in getting back to you. I just finished a 3-month long oral treatment of Solvaldi/Olysio. No virus found~ but of course, I have to remain that way for 6 months to be considered “cured”. The treatment is quite expensive ($150,000), but I would recommend trying it if your insurance will pay for it, or you can get financial assistance (ask your provider about that). There were hardly any side effects, just mild headache occasionally, and some tiredness. It was a piece of cake. Message me on Twitter or Google+ if you have any questions.

  • Skeptic

    Why don’t the clinicians at FDA fast track some of the products in early stage development that have achieved there safety data. Perhaps an FDA’er would like a few doses of Interferon to see what you go through for “increased effectiveness.” These treatments are costly and offer little in terms of efficacy.

  • Kevin

    I had Hep C Genotype 4. I took Bristol Myers Squibb’s three all oral drugs. I took them for 12 weeks and I was undetectable by week 4. I stopped the drugs on April 23, 2013 and hopefully the virus will not return. I go for my 4-week-off-the-drugs blood test next week. Hopefully, the virus hasn’t returned. If it hasn’t returned by 8th week off the drugs then I will be considered cured. The only side-effect from the drugs was a slight headache and that was the worst of it. Even though 60 people before me have remained virus-free for a year, the FDA is no where near ready to approve the BMS drugs, it makes no sense.

    • jim

      pls Mr. kevin can you name all oral drugs of Bristol Myers Squibb’s ? i need to buy them too. thank you so much

  • Hi Kevin, pls how do I get the drug? I have type 4 and NHS refused to treat me with Teleprevir. Pls kindly help me. My email is [email protected] or pls call me on 07877988240. Pls help me

  • How did you get the Bristol Mayer Squibbs medication for type 4

    • smashmum

      How do I get Bistol Mayer Squibbs all oral meds

  • Guest
  • Apathetic&tired

    Blah, Blah, Blah! Anything the FDA does takes at least 10 years unless the manufacturer pays them up front!

  • guest

    what after i have
    HCV 1 I am Egyptian I talk Pegases and interferon for 1 year, within 5 month
    from the treatment the result was indictable
    , i complete the 1 year course,
    and after 6 months from finishing the course again PCR result deceted, i don’t
    know I start this killing course again even with this protease medication, or I
    wait may be I can leave more rather than taking this killing courses, I need advice???

    Note my test result
    IL28B RS 12979860 genotype I found
    my type C/T