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Post Info TOPIC: FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1


Guru

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FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1
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Thanks for your comments, Malcolm, it will be interesting to see how useful this drug proves to be, assuming it gets full FDA approval, which looks very likely.  Time will tell, and as you mentioned, I guess a lot depends on whether the price will be set at a realistic level. 

I see Sofosbuvir has now passed through the FDA Advisory Committee recommendation stage too, and I would think it`s just a formality for it to be approved.

 






__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



Guru

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Hi Jill,

I guess if the FDA goes on to approve Simeprevir, it will be a small step forward, and probably be the end of Incivek and Victrelis in the USA. It can only be hoped that Janssen will put a reasonable price on it.

Simeprevir does have the advantage of being one pill a day, rather than the heavy pill loads of the other antiproteases. The Sx effects appear to be less than Incivek but I'm surprised that only 1178 patients were trialled.(Quest 1, 2 and Promise). The SVR figures appear slightly better, but the IL28B allele still plays a big part in response rate. Geno 1b does better than Geno 1a. The number of cirrhotics treated is not announced, but the sub-group of F3-4 patients has a decreased SVR rate of ~60%.  I wonder how the stated percentages eligible for RGT will translate into real practice.

So, perhaps another treatment possibility for the Geno 1's. I'm not sure it will be used much- it may eventually find a place in combination with other new DAA's. Cheers.

 



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



Guru

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Oct. 24, 2013 - Janssen Research & Development, LLC (Janssen) announced today that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously (19 to 0) to recommend approval of the investigational protease inhibitor simeprevir (TMC435) administered once daily as a 150 mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. The Advisory Committee recommended the approval of simeprevir based on analyses of data from clinical trials in patients who are treatment naive or who have failed previous interferon-based therapy.

"We are pleased with the positive recommendation from the Advisory Committee for simeprevir and appreciate the rigorous review of our data," said Katia Boven, M.D., Medical Department Head, Infectious Diseases and Vaccines, Janssen. "It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make simeprevir available to patients with genotype 1 chronic hepatitis C."

Full article...

http://www.prnewswire.com/news-releases/fda-advisory-committee-recommends-approval-of-simeprevir-for-combination-treatment-of-genotype-1-chronic-hepatitis-c-in-adult-patients-229144461.html



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 

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