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Post Info TOPIC: (CHMP), the scientific committee of the European Medicines Agency Green Lights SOFOSBUVIR


Guru

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RE: (CHMP), the scientific committee of the European Medicines Agency Green Lights SOFOSBUVIR
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i wonder how Sofosbuvir will be called in China and India :)



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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!




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Hi Matt, interesting topic.  I wouldn`t say that Europe is jumping on the bandwagon as such with Sofosbuvir, it`s more that it`s going through the due processes for a new drug.  When Gilead submitted their application to the FDA earlier this year it was granted priority review status and so it`s been fast tracked in the US.  In due course other countries will follow suit, but it takes time.  Now that the CHMP have indicated their approval for Sofosbuvir it then has to be reviewed by the EC (European Commission) which has the authority to approve medicines for use in the 28 countries of the EU (European Union), which could be early next year.  Of course cost will be a major consideration too for individual countries.  Here in the UK it will have to go through the process of being reviewed and approved for use within our NHS (National Health Service), which because of budget restraints is already restricting the availability of Incivek and Victrelis to the most needy cases.  Interesting to note that the brand name to be used in Europe will be `Sovaldi`.



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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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Hey All as noted by SuziQ

Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on sofosbuvir.

This will have great ramifications for all upcoming and existing/ current competing Meds. The Gilead stock jumped nearly 4 Points with this news.

Interesting that the E.U. jumped right on the Sofosbuvir band wagon, actually its a no brainier when you think about all the great results that have been repeated over and over again without side effects. 

It really makes me wonder why its takes so long to approve such a well documented drug, their must be a lot more to the process having to do with monetary, political and distribution than we are aware of.

I hope with these shorter trial times of 8-12 weeks that would allow for much faster incubation period, then new HCV drugs like Mercks, and Gileads Single combo pill could come to market in a much faster time frame.

I for one think that once the track record in larger trials studies (Phase III) are positively established they should file for approval.

I have several basis for this argument  (1) The current SOC is near barbaric (2) The new DAA's need all the competition they can get so price can modulate. (3) There is a hidden Pandemic worldwide that could be addressed.

What say you Europe?

Matt        



-- Edited by Matt Chris on Friday 22nd of November 2013 08:46:58 PM

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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! 

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