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FDA approves Merck's HCV combo

January 29, 2016 2:29 AM UTC

FDA approved Zepatier grazoprevir/elbasvir ( MK-5172/MK-8742) from Merck & Co. Inc. (NYSE:MRK) with or without ribavirin to treat HCV genotypes 1 and 4 in adults. Merck said Thursday it would launch the drug within seven business days at a list price of $54,600 for a 12-week regimen.

The drug's label includes a warning that about 1% of clinical trial participants had liver enzymes elevated above five times the upper limit of normal amounts, generally at or after the eighth week of treatment. Merck also said doctors should screen genotype 1a patients for "certain viral genetic variations" prior to starting treatment. ...