Gilead's HCV drug gets green light in USA
10th December 2013
Regulators in the USA have given the green light to Gilead Sciences’ Sovaldi,
the first drug that has demonstrated safety and efficacy to treat hepatitis C
infection without the need for interferon.
The US Food and Drug Administration has approved Sovaldi (sofosbuvir), a
nucleotide analogue inhibitor that blocks a specific protein needed by the hep C
virus to replicate. The thumbs-up is based on six clinical trials consisting of
1,947 participants who had not previously received treatment for their disease
or had not responded to other drugs.