Hep C Discussion Forum

Members Login
Username 
 
Password 
    Remember Me  
Chatbox
Please log in to join the chat!
Post Info TOPIC: 7977 Sofosbuvir Priority Review


Guru

Status: Offline
Posts: 5627
Date:
7977 Sofosbuvir Priority Review
Permalink  
 


Excellent news, thanks Jim! And thanks to Vicky too.. hope she`s doing well! smile



__________________

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.



Guru

Status: Offline
Posts: 730
Date:
Permalink  
 

From Vicky:

Designation for Sofosbuvir for the Treatment of Hepatitis C

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 7, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company's New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options. Gilead filed the NDA for sofosbuvir on April 8, 2013, and FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013.

The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-nave patients with genotype 1, 4, 5 and 6 HCV infection. Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O'Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)

http://natap.org/



-- Edited by JIme on Saturday 8th of June 2013 11:34:42 AM

__________________

jim

GT1a, St2 Lv2 last biopsy 2002, VL 11.4m, start triple tx 9/30/11

VL 470 @4wks.....VL 22,000 @8wks stopped tx

Round 2- Started 3/16/12 PSI-7977, BMS-790052, Riba Undetectable day 14

Did 24 weeks Still UND 12 weeks post tx, SVR24!!!!!!! 2/14/13

Page 1 of 1  sorted by
 
Quick Reply

Please log in to post quick replies.

Legal Disclaimer:

THIS FORUM, IT'S OWNERS, ADMINISTRATORS, MODERATORS AND MEMBERS DO NOT AT ANY TIME GIVE MEDICAL ADVICE AND IN ALL CASES REFER ANYONE HERE TO SEEK APPROPRIATE MEDICAL ADVICE FROM THEIR DOCTOR.