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Gilead Sciences Inc announces US FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection


Monday, 7 Apr 2014 08:30am EDT 

Gilead Sciences Inc:US FDA granted priority review to company's NDA for once-daily fixed-dose combination of NS5A inhibitor ledipasvir (LDV) 90 mg and nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults.Gilead filed NDA for LDV/SOF on Feb. 10, 2014, and FDA has set target action date under Prescription Drug User Fee Act (PDUFA) of Oct. 10, 2014.FDA also assigned LDV/SOF a Breakthrough Therapy designation.Data submitted in the NDA are from three Phase 3 studies, ION-1, ION-2 and ION-3, and support the use of LDV/SOF in adults with genotype 1 HCV infection.Marketing application for LDV/SOF is also under review in the European Union. 

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