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Gilead submits fixed-dose combination ledipasvir/sofosbuvir HCV tablet for FDA approval
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A new drug application has been submitted to the FDA by Gilead Sciences for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (90 mg) and the nucleotide analog polymerase inhibitor sofosbuvir (400 mg) for treating chronic hepatitis C genotype 1 infections in adults.
“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, PhD, Gilead Sciences executive vice president of research and development and chief scientific officer, said in a statement. “Based on the data from the Phase 3 ION studies, the [ledispasvir/sofosbuvir] LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as 8 weeks and without the need for interferon injections or ribavirin [RBV].”
Earlier, the FDA gave LDV/SOF breakthrough therapy designation.
In its statement, Gilead said the new drug application is based on a trio of Phase 3 studies in which nearly 2,000 genotype 1 HCV patients were randomly assigned to the fixed-dose combination, with or without RBV, for durations of eight, 12 or 24 weeks.