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Hep C Discussion Forum -> General Discussion -> Gilead's (GILD) Sofosbuvir FDA Panel Review Date Set for October 25th
Post Info TOPIC: Gilead's (GILD) Sofosbuvir FDA Panel Review Date Set for October 25th
mehru


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RE: Gilead's (GILD) Sofosbuvir FDA Panel Review Date Set for October 25th
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http://www.sparkimg.com/emoticons/sun.gif

Sounds like the most positive piece of news I've seen yet! Thanks for posting this Matt. I like the domino effect idea.

 



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Geno 1a, Stage 3-4 early cirrhosis (labs, recent biopsy, MRE elastography to confirm), 1999 rebetron trial with inf/riba *non/partial responder at 16 wks.  4/2013 started victrelis triple tx - had to discontinue after 2 weeks due to rash.

 
lauralou57


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I believe that I read that the approximate FDA approval date was December 8, 2013.

I think it is important to remember that this approval is for sofosbuvir alone with ribaviran and NOT for the combination pill of sofosbuvir and ledipasvir together.

I also believe I read that the FDA has many advisory committees as they do the Antiviral Drugs Advisory Committee.

But, as a genotype 1a null responder, I am very excited about the new interferon-free drugs that are coming.

My wish and prayers is for SVR 100% for everyone!



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Alico 222


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Where does it say the date and will approval be same in eu... Not sure how this all works.
When can we expect it in Britain? Do you know!

Cheers and thanks
Alici

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Ali
Matt Chris


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Looks like the FDA  is not going to drag its feet on this review of Sofosbuvir after all.
 
Yahoo! ( how does one yodel in print)
 
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
 
Name of Committee: Antiviral Drugs Advisory Committee.  General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues
 
Excerpt from article 
 
Agenda: The committee will discuss new drug application (NDA) 204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by Gilead Sciences, Inc. (Nasdaq: GILD), with a proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.
 
Could start a domino effect on HCV drugs being approved in the coming 14 months , it's very exciting times, yahoo! 
 
Matt 


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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
Loopy Lisa


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That is fantastic news! Whooop!

Here in the EU they are about 1 month behind also with fast tracking (we do not have the FDA that is American, we have the European Commission). My Doctor said it will be approved next year in Europe (dending on individual countries policies though).

I am looking forward to getting this baby into my body!

Woohooooo :P

(sorry feeling excited) :D



-- Edited by Loopy Lisa on Friday 13th of September 2013 06:37:19 PM

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Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 
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Hep C Discussion Forum -> General Discussion -> Gilead's (GILD) Sofosbuvir FDA Panel Review Date Set for October 25th
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