Gilead files for US approval of ledipasvir/sofosbuvir combination for hepatitis C

US biotech major Gilead Sciences (Nasdaq: GILD) has submitted a New Drug Application (NDA) to the US Food and Drug Administration for a once-daily ledipasvir/sofosbuvir fixed-dose combination for genotype 1 hepatitis C.

The combination of NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg is indicated for the treatment of chronic hepatitis C genotype 1 infection in adults. The data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (HCV) infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Approximately 75% of people infected with HCV in the USA have the genotype 1 strain of the virus.

Norbert Bischofberger, executive vice president of R&D and chief scientific officer, said: “Today's filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen. Based on the data from the Phase III ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin.”