Sofosbuvir regulatory update

Gilead 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. ...