Gilead's Sofosbuvir will Receive an Accelerated Assessment by EMA

Posted in the Hepatitis Forum

HCV New Drugs

Dearborn, MI

#1 May 21, 2013
European Medicines Agency Validates Gilead's Marketing Application for Sofosbuvir for the Treatment of Hepatitis C
-- Once-Daily Sofosbuvir will Receive an Accelerated Assessment by EMA;
Designation Granted to New Medicines of Major Public Health Interest --
FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 21, 2013-- Gilead Sciences, Inc.(Nasdaq: GILD) today announced that the company's Marketing Authorisation Application (MAA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection, which was submitted to the European Medicines Agency (EMA) on April 17, 2013, has been fully validated and is now under assessment. The data submitted in this MAA 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-na´ve patients with genotype 1, 4, 5 and 6 HCV infection.
On April 18) Gilead Submited New Drug Application to U.S. FDA for Sofosbuvir (GS-7977) for the Treatment of Hepatitis C

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