Developing medicines that reverse or even slow the progress of Alzheimer’s disease has proved to be a tough task for the pharma sector, and it is looking for ways to ensure regulation does not pose an additional and possibly insurmountable barrier. A workshop on Alzheimer’s disease (AD), at the London headquarters of the European Medicines Agency (EMA), heard from specialists debating the latest advances in understanding of the pathophysiology of AD and the discovery of disease-modifying treatment targets.
Other topics included: the changing diagnostic criteria for AD, including early and asymptomatic disease stages, and their impact on clinical trial design; the scientific and regulatory approaches to facilitating drug development and registration; the choice of outcome parameters and need for distinct assessment tools regarding different stages of the disease; the potential use of biomarkers to develop medicines targeting different stages of the disease; and treatments of associated neuropsychiatric and other symptoms.
Pharma companies are struggling to meet EMA’s regulatory standard for approving Alzheimer’s medicines
A member of a European Federation of Pharmaceutical Industries and Associations (EFPIA) working group, Dr Thomas Blaettler, of Roche, warned that pharma companies are struggling to meet EMA’s regulatory standard for approving Alzheimer’s medicines. Regarding those approved for their disease modifying effects, EMA rules say a drug test must demonstrate that it ‘delays the underlying pathological or pathophysiological disease processes and when this is accompanied by improvement in clinical signs and symptoms of the dementing condition’.
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