Merck gets US FDA nod for drug to treat hepatitis C virus
US pharma giant Merck & Co (NYSE: MRK) on Friday said the US Food and Drug Administration has approved its Zepatier (elbasvir and grazoprevir) to treat chronic hepatitis C virus (HCV) following priority review.
The regulator had previously granted two Breakthrough Therapy designations to Zepatier, for the treatment of chronic HCV GT1 infection in patients with end stage renal disease on hemodialysis, and for the treatment of patients with chronic HCV GT4 infection.
Roger Perlmutter, president, Merck Research Laboratories, said: "Continued innovation is needed to help address the worldwide epidemic of chronic hepatitis C virus infection. Our clinical program was designed to study a broad range of patients infected with the hepatitis C virus, including difficult-to-treat patients such as those with stage 4 or 5 chronic kidney disease. The approval of Zepatier is a testament to Merck's unwavering commitment to improving therapy for patients with hepatitis C virus infection, and we are eager to bring this innovation to patients and physicians in the US."
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