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faldaprevir (BI 201335)

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Collapse Summary General Information
Company Boehringer Ingelheim GmbH
DescriptionOral HCV NS3/4A protease inhibitor
Molecular Target HCV NS3/4A protease complex
Mechanism of ActionViral protease inhibitor
Therapeutic ModalitySmall molecule
Latest Stage of DevelopmentRegistration
Standard IndicationHepatitis C virus (HCV)
Indication DetailsTreat chronic HCV genotype 1 infection in treatment-experienced patients; Treat chronic HCV genotype 1 infection in treatment-naïve patients; Treat genotype 1 hepatitis C, including difficult-to-cure populations such as those with HIV co-infection or advanced liver disease; Treat HCV genotype 1 infection; Treat HCV genotype 1 infection in patients co-infected with HIV
Regulatory Designation

U.S. - Fast Track (Treat chronic HCV genotype 1 infection in treatment-naïve patients);
EU - Accelerated Assessment (Treat genotype 1 hepatitis C, including difficult-to-cure populations such as those with HIV co-infection or advanced liver disease)

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