The European Medicines Agency published a “Reflection paper on chronic liver diseases (PBC, PSC, and NASH)” in Autumn 2018. Elmer Schabel gives a detailed display of the contents of this first regulatory guidance with regard to NASH, as well as a preliminary evaluation of the initial feedback and input received by stakeholders.
The first major consideration from the paper was that an “acceptable regulatory strategy” for companies may rely on the interim evaluation of intermediate endpoints. This implies that conditional approval of therapies may be possible, with full approval achieved later. Secondly, evaluations currently rely on histology, which requires a liver biopsy. Therefore, the development of non-invasive biomarkers is encouraged as a future replacement for biopsies.
Elmer also covers the reflections on the patient population of NASH, as well as suitable study design and clinical endpoints. To hear the whole summary and the interesting feedback from the stakeholders meeting, watch the whole presentation using the links below.
The EMA reflection paper on chronic liver disease and its implications for drug development in NASH
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The European Medicines Agency published a “Reflection paper on chronic liver diseases (PBC, PSC, and NASH)” in autumn 2018. Elmer Schabel gives a detailed display of the contents of this first regulatory guidance with regard to NASH, as well as a preliminary evaluation of the initial feedback and input received by stakeholders. |
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