The FDA is reviewing Gilead Sciences' new drug application (NDA) for a fixed dose combination of sofosbuvir (Solvadi) and velpatasvir to treat genotype 1-6 hepatitis C virus infection.
The FDA is reviewing Gilead Sciences’ new drug application (NDA) for a fixed dose combination of sofosbuvir (Solvadi) and velpatasvir to treat genotype 1-6 hepatitis C virus infection.
If the FDA approves the drug, the once-daily combination would be the first all-oral, pan-genotypic single tablet for the chronic infection.
The NDA includes data from clinical studies that examined the use of sofosbuvir (SOF) and velpatasvir (VEL) for 12 weeks in patients with genotype 1-6 hepatitis C infection, including those with compensated cirrhosis.
The NDA also includes information about 12 weeks of the SOF/VEL treatment with ribavirin for patients with decompensated cirrhosis.
"As the first fixed-dose combination of 2 pan-genotypic, direct-acting antivirals, SOF/VEL represents an important step forward in the treatment of patients with hepatitis C,” said Norbert
Bischofberger, executive vice president of research and development and chief scientific officer at Gilead. “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.”
The FDA has granted breakthrough therapy designation to Gilead for the combination treatment.
Thus far, adverse effects associated with the sofosbuvir and velpatasvir treatment have been headache, fatigue, and nausea.