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Hep C Discussion Forum -> Hep C News -> European Commission Approves Daklinza (daclatasvir) Across Multiple Genotypes
Post Info TOPIC: European Commission Approves Daklinza (daclatasvir) Across Multiple Genotypes
Loopy Lisa


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RE: European Commission Approves Daklinza (daclatasvir) Across Multiple Genotypes
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I hope they blow Solvadi to the wind....greedy company!



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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 
Tig


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Thanks for the great post Jill! Excellent advance across the EU and I hope we can see the costs of this, as well as that of the associated drugs reduced to an affordable level. I want to see what Gilead will do when they counter with Ledispavir next month. This is going to be a battle between Big Pharm at it's ugliest level....

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Cinnamon Girl


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Wednesday, August 27, PRINCETON, N.J. - Bristol-Myers Squibb today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor, for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C in adults.  Daklinza, when used in combination with sofosbuvir, is an all-oral, interferon-free regimen that provided cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors.  Daklinza is the first NS5A complex inhibitor approved in the European Union (EU) and will be available for use in combination with other medicinal products, providing a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.

Today`s approval allows for the marketing of Daklinza in all 28 Member States of the EU.  The marketing authorization for Daklinza follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), a designation that is granted to new medicines of major public health interest.

Note - Commercial availability of Daklinza in the EU will be determined by individual Member States.

Link to full press release, including recommended treatment regimens and durations...

http://news.bms.com/press-release/rd-news/european-commission-approves-bristol-myers-squibbs-daklinza-daclatasvir-across

 



__________________

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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