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8 Jul 2016

USFDA approved Epclusa for treatment of chronic Hepatitis C virus infection

Brand Name: Epclusa
Type: Fixed Dose Combination
Molecule: Velpatasvir + sofosbuvir
Manufactured By: Gilead Sciences, Inc
Marketed By: Gilead Sciences, Inc
Velpatasvir/sofosbuvir (trade name Epclusa) is a two-drug combination for the treatment of hepatitis C. It is administered as a single daily pill containing 100 mg of the viral NS5A inhibitor velpatasvir and 400 mg of sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase. It is the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
Epclusa was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Gilead depends heavily on hepatitis-C drugs portfolio for the revenue. Gilead is global leader in HCV market with alomost 90% market share.
Gilead’s HCV portfolio includes leading HCV drugs like HARVONI & SOVALDI.

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