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Hep C Discussion Forum -> Hep C News -> FDA grants Priority Review for 3 New Drug Applications for Daklinza
Post Info TOPIC: FDA grants Priority Review for 3 New Drug Applications for Daklinza
Cinnamon Girl


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Date:
FDA grants Priority Review for 3 New Drug Applications for Daklinza
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Bristol Myers-Squibb announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review three supplemental New Drug Applications for Daklinza(daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin.

The applications are for the treatment of patients with chronic hepatitis C (HCV) coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.

Link to full details of press release ...

http://news.bms.com/press-release/us-fda-grants-priority-review-daklinza-daclatasvir-sndas



__________________

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 -> FDA grants Priority Review for 3 New Drug Applications for Daklinza
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