BioCentury
ARTICLE | Company News

EMA grants accelerated assessment to Gilead's sofosbuvir

May 22, 2013 12:01 AM UTC

Gilead Sciences Inc. (NASDAQ:GILD) said EMA accepted for accelerated assessment an MAA for sofosbuvir to treat chronic HCV infection. An accelerated assessment shortens the review period to 150 days from 210. Gilead said the MAA covers the use of sofosbuvir in combination with ribavirin as an all-oral therapy to treat HCV genotypes 2 and 3 infection; and sofosbuvir in combination with ribavirin and pegylated interferon to treat HCV genotypes 1, 4, 5 and 6 infection in treatment-naïve patients. ...