EATG » FDA guidance for industry on DAA development for hepatitis C

FDA guidance for industry on DAA development for hepatitis C

FDA published a final guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. The guidance can be found at

This guidance assists sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the pre-investigational new drug application stage through the new drug application and post-marketing stages.  This guidance finalizes the draft guidance of the same name issued in May 2016.  Major changes from the draft include the following:

  • Modification of several sections to focus on interferon-free DAA regimens.
  • Additional clarification on trial designs for combinations of investigational DAAs with or without ribavirin.
  • Additional clarification on the recommended trial population to include patients with clinical or laboratory evidence of CHC disease.
  • Additional details on DAA drug development in patients with decompensated cirrhosis.
  • Additional clarification on efficacy endpoints.
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News categories: Hepatitis, Guidelines, EMA/FDA