REPORT
Consultation on medicines to treat Alzheimer’s disease
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.
A
ccording to the World Health Organisation, 35.6 million people have dementia
worldwide and this number is expected to double by 2030.
There are currently over 20,000 people with dementia living in Northern Ireland. People with dementia here are more likely to get a diagnosis than anywhere else in the UK, but there is still a huge amount to do to improve the care and support people with dementia get and to create dementia friendly communities.
If current trends continue and no action is taken, the number of people with dementia in the UK is forecast to increase to 1,142,677 by 2025 and 2,092,945 by 2051, an increase of 40% over the next 12 years and of 156% over the next 38 years.
Many people talk about a 'dementia time bomb' that the state cannot cope with. This is misleading. A steady, rather than dramatic, growth is expected over the next 25 years.
Recent progress in understanding the pathophysiology of Alzheimer’s Disease (AD) suggests that the biological changes associated with the disease start to occur as early as 10 to 20 years prior to the emergence of clinical symptoms. Experimental medicines should therefore be evaluated in earlier disease stages as certain
treatments may be more effective at that stage than later in the illness.
EMA 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 AD in November 2014.
Dementia is a heterogeneous class of diseases and based on etiologic factors, pattern of impairment, course of dementia and laboratory and imaging tools, distinct subtypes of dementia syndromes are identifiable.
AD is the most common cause of dementia, followed by vascular dementias (vaD) or mixed forms of AD and vaD. Other forms of neurodegenerative disorders (e.g. Lewy body disease, frontotemporal dementia) are accompanied with dementia as well. For regulatory purposes high specificity but also high sensitivity of diagnostic criteria will be needed.
This document focuses on AD, while other forms of dementia will only be briefly addressed.
The field of AD research and development witnessed a recent
paradigm shift in the diagnostic framework of AD which is now considered a continuum with a long- lasting pre-symptomatic phase, with evidence of AD neuropathology, which precedes 10-20 years the onset of dementia. As the biomarker field is evolving, the possibility to detect disease changes and progression in vivo, opens new regulatory scenarios including the possibility to intervene directly on the neuropathology before the appearance of symptoms.
There is now a consensus that treatment options should be evaluated in earlier disease stages before the full picture of dementia is reached. While the general approach for symptomatic drug development in mild to moderate and severe AD is still valid, this draft Guidance aims at integrating the requirements for development programmes which start earlier in the disease course with the necessary adaptations to the distinct manifestations of the illness at these stages.
The revised guideline specifically addresses the: • Impact of new diagnostic criteria for Alzheimer’s disease, including early and even asymptomatic disease stages, on clinical trial design; • 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); • 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.); • Design of long-term efficacy and safety studies.
The EMA considers dementia a key public health priority and has worked with patient representatives, regulators, the pharmaceutical industry and independent experts while compiling the draft guidelines.
Although the last few years have seen a number of Alzheimer’s diagnostics approved, among them GE Healthcare vizamyl (flutemetamol) and Piramal's Neuraceq (florbetaben F18), research progress for a treatment has been slow.
Last year Roche and Evotec's sembragiline failed a phase II trial and Pfizer recently announced it has halted development of its candidate, PF-05212377, after it too failed to meet objectives in a phase II trial.
The consultation runs until 31 July 2016. n
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