Gilead Sciences announced that the FDA has granted priority review to its New Drug Application (NDA) for a once-daily fixed-dose combination of ledipasvir (LDV) 90mg, an NS5A inhibitor, and sofosbuvir (SOF) 400mg, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C genotype 1 infection in adults. The FDA also assigned LDV/SOF a Breakthrough Therapy designation.
The submission was based on data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies supported the use of ledipasvir/sofosbuvir in adults with genotype 1 HCV infection, with a treatment duration of 8 or 12 weeks depending on prior treatment history and whether they have cirrhosis.
Sovaldi (sofosbuvir) was previously approved as a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection.
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