CHMP backs Gilead's sofosbuvir

EMA's CHMP backed approval of Sovaldi sofosbuvir ( GS-7977) from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic HCV in adults. 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. Sofosbuvir is under accelerated assessment in the EU, which shortens the review period to 150 days from 210. Last month, FDA's Antiviral Drugs Advisory Committee unanimously backed approval of the single isomer form of a nucleotide analog HCV NS5B polymerase inhibitor, which is under Priority Review in the U.S., with a Dec. 8 PDUFA date (see BioCentury, Nov. 11).

Additionally, CHMP recommended compassionate use of sofosbuvir in combination with daclatasvir ( BMS-790052) from Bristol-Myers Squibb Co. (NYSE:BMY) to treat chronic HCV genotype 1 infection in patients who are at high risk of liver decompensation or death. Last month, CHMP also recommended compassionate use of sofosbuvir in select patients waiting for a liver transplant or who have had a liver transplant (see BioCentury Extra, Oct. 25). ...