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Merck Reaches Hepatitis C Market With Zepatier

Grazoprevir/elbasvir doublet has a much narrower indication than other hepatitis C therapies, but it could have an edge in those subpopulations.

Merck & Co. Inc. is third to market with an all-oral combination regimen for hepatitis C with FDA's Jan. 28 approval of Zepatier, its once-daily, single-pill combo of grazoprevir and elbasvir. But for this product to make a mark in the ultra-competitive HCV space, Merck will have to capitalize on its approval in a pair of subpopulations, genotype 4 and genotype 1 patients with end-stage renal disease who are on dialysis.

The fixed-dose combination of the second-generation protease inhibitor grazoprevir (MK-5172) 100 mg and the NS5A inhibitor elbasvir (MK-8742) 50 mg was filed for approval May 28 and granted priority review ([A#14150529002]). All-oral combination products already on the market for HCV include Gilead Sciences Inc

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US FDA Restoring Some Library Resources

 
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