The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV) infection.2 18 Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program and clinical trial designs for the development of drugs and biologics to support an indication for the treatment of chronic HDV infection.
FDA encourages sponsors to communicate with the Division of Antiviral Products (DAVP)
24 through the pre-investigational new drug application (pre-IND) consultation program to discuss the development of drugs with unique considerations based on mechanism of action, novel treatment approaches, or the use of novel biomarkers. This draft guidance is intended to serve as a focus for continued discussions among DAVP, pharmaceutical sponsors, the academic community, and the public.
This guidance focuses on considerations that are specific to HDV drug development. General topics in early phase drug development, statistical analysis, and clinical trial design are addressed in the International Conference on Harmonisation (ICH) guidances for industry E9 Statistical Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001). The draft guidance for industry Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment (November 2018) also contains information that is relevant to HDV drug development…