Gilead Sciences has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for an investigational, once-daily fixed-dose combination of sofosbuvir (SOF) and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor to treat chronic genotype 1-6 hepatitis C virus (HCV) infection.
A nucleotide analog polymerase inhibitor, sofosbuvir was approved as Sovaldi in December 2013.
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The NDA was based on data from clinical studies that explored the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.
Gilead chief scientific officer and research and development executive vice-president Norbert Bischofberger said: "As the first fixed-dose combination of two pan-genotypic, direct-acting antivirals, SOF/VEL represents an important step forward in the treatment of patients with hepatitis C.
"Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes.
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"SOF/VEL complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing."
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By GlobalDataThe data was from four Phase III Astral trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6.
More than 1,035 patients were treated with the combination for 12 weeks in the Astral-1, Astral-2 and Astral-3 trials, of which 1,015 achieved the primary efficacy endpoint of SVR12.
The ASTRAL-4 study randomised 267 patients with decompensated cirrhosis to receive 12 weeks of SOF/VEL with or without ribavirin, or 24 weeks of SOF/VEL.
According to the company, patients who received SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94%, while those who received SOF/VEL for 12 weeks and 24 weeks achieved SVR12 rates of 83% and 86% respectively.
The company intends to submit a regulatory application for approval of SOF/VEL in the European Union (EU) by the end of the year.
