Gilead submits NDA for hepatitis C treatment
Gilead submitted the NDA to the U.S. Food and Drug Administration for a once-daily, fixed-dose combination of a 90 milligram dose of the NS5A inhibitor ledipasvir combined with a 400 milligram dose of the nucleotide analog polymerase inhibitor sofosbuvir. Gilead submitted data in the NDA that supports the use of LDV/SOF in patients with genotype I HCV infection with a treatment duration of eight or 12 weeks, dependent on whether they have cirrhosis and their prior treatment history.
Approximately 75 percent of people with HCV in the U.S. have the genotype I strain of the virus.
"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," Norbert Bischofberger, the executive vice president of research and development and the chief scientific officer at Gilead, said. "Based on the data from the Phase III ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype I patients in as little as eight weeks and without the need for interferon injections or ribavirin."
The NDA is supported by three Phase III studies in which close to 2,000 genotype I HCV patients either received the fixed-dose combination with or without ribavirin for treatment durations of eight, 12 or 24 weeks.
The FDA assigned LDV/SOF as a breakthrough therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options.
LDV/SOF is an investigational product as its safety and efficacy has not yet been established.