EMA Issues Revised Draft Guideline on Drug Development for Alzheimer’s Disease

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-02-2016 15:52


The European Medicines Agency (EMA) has released a revised guideline on medicines for the treatment of Alzheimer’s disease and other types of dementias for a six-month public consultation. Stakeholders are invited to send their comments by July 31, 2016.

EMA said it considers dementia as a key public health priority and follows a multi-stakeholder approach to facilitate research and development of more effective medicines. The revised guideline takes into account comments received at EMA’s workshop on the clinical investigation of medicines for the treatment of Alzheimer's disease in November 2014. This workshop brought together a wide range of stakeholders, including patient representatives, regulators, pharmaceutical industry and independent experts. The aim of the workshop was to ensure that during the revision of its guideline, EMA would be able to consider the most up-to-date scientific developments in understanding and treating Alzheimer’s disease and views from experts in the field. The revised guideline also builds on EMA scientific advice provided for a number of specific development plans for Alzheimer’s disease in recent years, as well as the qualification of several biomarkers for the selection of patients in clinical trials.

The revised guideline specifically addresses the: (1) impact of new diagnostic criteria for Alzheimer’s disease, including early and even asymptomatic disease stages, on clinical trial design; (2) choice of parameters to measure trial outcomes and the need for distinct assessment tools for the different disease stages in Alzheimer’s (different signs and symptoms, differences in changes over time, severity); (3) potential use of biomarkers and their temporal relationship with the different phases of Alzheimer’s disease at different stages of medicine development (mechanism of action, use as diagnostic test, enrichment of study populations, stratification of subgroups, safety and efficacy markers etc.); and (4) design of long-term efficacy and safety studies.

Comments received during the consultation will be taken into account in the finalization of the guideline.

Source: EMA


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