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Galexos, Olysio, Sovriad, simeprevir (TMC435) (formerly TMC435350)

Also known as: HCV Inhibitor

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Company Medivir AB
DescriptionHCV NS3/4A protease inhibitor
Molecular Target HCV NS3/4A protease complex
Mechanism of ActionViral protease inhibitor
Therapeutic ModalitySmall molecule
Latest Stage of DevelopmentMarketed
Standard IndicationHepatitis C virus (HCV)
Indication DetailsTreat chronic HCV genotype 1 infection; Treat chronic HCV genotype 1 infection in patients who failed prior therapy; Treat chronic HCV genotype 1 infection in patients who failed to respond to previous interferon-based therapy; Treat chronic HCV genotype 1 infection in patients who relapsed after previous interferon-based therapy; Treat chronic HCV genotype 1 infection in treatment-naïve patients; Treat chronic HCV genotype 1 infection in treatment-naïve patients and in patients who failed to respond/relapsed after previous interferon-based therapy; Treat chronic HCV genotype 1b or 4 infection in non-cirrhotic, treatment-naïve patients; Treat chronic HCV genotype 4 infection; Treat cirrhotic patients with chronic HCV genotype 1 infection; Treat HCV genotype 1 infection; Treat HCV genotype 1 infection in adult patients with compensated liver disease; Treat HCV genotype 1 infection in patients co-infected with HIV-1; Treat HCV genotypes 1 and 4 infection; Treat non-cirrhotic patients with chronic HCV genotype 1 infection; Treat non-cirrhotic, treatment-naïve patients with chronic HCV genotype 1 infection
Regulatory Designation

U.S. - Fast Track (Treat chronic HCV genotype 1 infection);
U.S. - Priority Review (Treat chronic HCV genotype 1 infection);
U.S. - Priority Review (Treat HCV genotype 1 infection in adult patients with compensated liver disease);
EU - Standard Review (Treat chronic HCV genotype 1 infection);
EU - Standard Review (Treat chronic HCV genotype 4 infection);
EU - Standard Review (Treat HCV genotypes 1 and 4 infection);
Japan - Standard Review (Treat chronic HCV genotype 1 infection);
Canada - Standard Review (Treat chronic HCV genotype 1 infection)

Partner

Johnson & Johnson


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