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Hep C Discussion Forum -> Hep C News -> BMS Receives U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Regimen
Post Info TOPIC: BMS Receives U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Regimen
Cinnamon Girl


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BMS Receives U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Regimen
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Monday, February 24, 2014 PRINCETON, N.J. -  Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV.  The designation is based on data from the company`s ongoing Phase III clinical trial program evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.

Full press release...

http://news.bms.com/press-release/bristol-myers-squibb-receives-us-fda-breakthrough-therapy-designation-all-oral-daclata&t=635288455840568400

 

 



__________________

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 U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Regimen
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