Gilead Gets Approved for Accelerated Assessment of Hep C Drug
Gilead Sciences receives EU green light for hepatitis C drug assessment
April 1, 2014 in Pharmaceutical Company Product News
Gilead Sciences has announced that the European Medicines Agency (EMA) has ratified its application for the assessment of a new treatment of chronic hepatitis C virus (HCV) infections.
The regulator has accepted the company’s marketing authorisation application for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic HCV genotype 1.
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