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Hep C Discussion Forum -> Hep C News -> BMS Receives Positive CHMP Opinion for daclatasvir (`Daklinza`) in the EU
Post Info TOPIC: BMS Receives Positive CHMP Opinion for daclatasvir (`Daklinza`) in the EU
Huey


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RE: BMS Receives Positive CHMP Opinion for daclatasvir (`Daklinza`) in the EU
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Sounds like the EU is going to get well,, I will keep my fingers crossed

__________________

  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 
Cinnamon Girl


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PRINCETON, N.J.-- 27 June, 2014. Bristol-Myers Squibb today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Daklinza (daclatasvir), an investigational, potent pan-genotypic NS5A complex inhibitor (in vitro), be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. This is the first positive opinion given by the CHMP for an NS5A complex inhibitor and will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).

"Through Bristol-Myers Squibb`s Early Access Programs in Europe more than 2,000 HCV patients with advanced liver disease have already been treated with Daklinza, in combination with sofosbuvir," said Elliott Levy, Head of Specialty Development, Bristol-Myers Squibb. "We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe".

Recently included in the European Association for the Study of the Liver`s (EASL) clinical practice guidelines for the management of HCV infection across genotypes, the EU marketing authorization application for Daklinza has gone through an accelerated review process. The positive CHMP opinion was based on data from multiple studies of Daklinza with other HCV agents, including sofosbuvir, for the treatment of chronic hepatitis C.

Full press release...

 

http://news.bms.com/press-release/bristol-myers-squibb-receives-positive-chmp-opinion-daklinza-daclatasvir-treatment-chr


__________________

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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Hep C Discussion Forum -> Hep C News -> BMS Receives Positive CHMP Opinion for daclatasvir (`Daklinza`) in the EU
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