2014年2月10日，Gilead向FDA提交了ledipasvir 90mg/sofosbuvir 400mg每日1次口服固定剂量复方的NDA，用于治疗成人基因1型慢性丙肝。之前获批的sofosbuvir仅供基因2,3型丙肝患者口服，而1型占美国丙肝患者的75%。AbbVie三联丙肝药咄咄逼人，Gilead提前出手了。

Gilead submits fixed-dose combination ledipasvir/sofosbuvir HCV tablet for FDA approval

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,

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.

关键词： Gilead FDA 口服复方丙肝药 ledipasvir 上市申请

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