The European Medicines Agency has released a concept paper regarding updates to the guideline for evaluating medicinal products designed for treating Hepatitis B, open for public input. This document aims to modernize the guideline for assessing medicinal products intended for Hepatitis B treatment, initially established by CHMP on February 23, 2006, and implemented on September 1, 2006. Recent years have witnessed numerous requests for scientific guidance on novel products and treatment strategies, particularly focusing on achieving functional cures through finite and combination therapies. Additionally, there have been advancements in antiviral and immunomodulatory treatments with distinct mechanisms from nucleos(t)ide analogues (NUCs) or peg-interferon alfa 2a (PEG-IFN). Consequently, revising the guideline is imperative to accommodate these advancements and their implications for clinical development programs.
Feedback is welcome until April 30, 2024, through the EU survey. Please note that the EMA may gather and process certain personal data from stakeholders and interested parties participating in the consultations. For more details, refer to the Specific privacy statement for public and targeted consultations available on the EMA’s website.
Read the full text here.
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