BioCentury
ARTICLE | Top Story

FDA approves Gilead's sofosbuvir

December 7, 2013 1:00 AM UTC

FDA approved Sovaldi sofosbuvir ( GS-7977) from Gilead Sciences Inc. (NASDAQ:GILD) in combination with ribavirin to treat HCV genotypes 2 and 3 infection -- making the drug part of the first all-oral, interferon-free regimen to be approved worldwide. Sovaldi is also approved in combination with ribavirin and pegylated interferon to treat HCV genotypes 1 and 4 infection. The nucleotide analog HCV NS5B polymerase inhibitor is the third drug with breakthrough therapy designation to be approved by FDA.

Gilead said Sovaldi will be available next week with a wholesale acquisition cost (WAC) of $28,000 for a 28-tablet bottle. According to the label for the once-daily pill, the recommended treatment duration for Sovaldi is 12 weeks for HCV genotypes 1, 2 and 4 infection; and 24 weeks for genotype 3 infection. Gilead also launched a program to provide assistance to patients who are uninsured, underinsured or who need financial assistance, including a co-pay assistance program. ...