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Gilead Sciences Inc files for U.S. approval of Ledipasvir/Sofosbuvir Fixed-Dose combination tablet for Genotype 1 Hepatitis C

Monday, 10 Feb 2014 04:05pm EST 

Gilead Sciences Inc:Submits a New Drug Application to the U.S. Food and FDA for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults.Says data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (HCV) infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis.Says about 75 pct of people infected with HCV in the United States have the genotype 1 strain of the virus.Says FDA has assigned LDV/SOF a Therapy designation, which is granted to investigational medicines that may offer advances in treatment over existing options.Says NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks.Says trial participants included patients who were treatment-na├»ve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis.Plans to file for regulatory approval of LDV/SOF in other geographies, including the European Union, in the first quarter of 2014. 

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30 Nov 2015