FDA is announcing the availability of a final guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” The purpose of this guidance is to provide general recommendations on the clinical development of drugs and biologics for the treatment of chronic HBV infection from the initial IND through the NDA/BLA and postmarketing phases. The guidance includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and phase 3 safety and efficacy trials. The guidance discusses phase 3 trial design considerations and efficacy endpoints for the development of finite duration therapies for the treatment of chronic HBV infection. Drug development considerations for specific subpopulations such as patients co-infected with hepatitis D virus or human immunodeficiency virus and for pediatric patients with chronic HBV infection are also included.
This guidance finalizes the draft guidance of the same name issued on November 2, 2018 (83 FR 55187). FDA provided clarifying edits to the final guidance and included additional information after considering comments received on the draft guidance. Changes from the draft to the final guidance include the following: Considerations and recommendations for studies evaluating oligonucleotide-based investigational drugs, considerations for drugs developed to modulate innate and adaptive immune responses, updates to trial design considerations, updates to recommendations for safety monitoring (including monitoring for hepatitis flares after treatment discontinuation), and updates to efficacy extrapolation from adult to pediatric patients.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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