efpia_comments_on_draft_guideline_on_clinical_investigation_of_medicines_for_the_treatment_of_alzhei - 5.8.2016 Submission of comments on'Draft


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5.8.2016 Submission of comments on 'Draft guideline on clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias’ - EMA/CHMP/539931/2014 Comments from: Name of organisation or individual EFPIA – Tiia Metiäinen ([email protected]) Please note that these comments and the identity of the sender will be published unless a specific justified objection is received. When completed, this form should be sent to the European Medicines Agency electronically, in Word format (not PDF). 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail [email protected] Website
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1. General comments Note from author: we have highlighted major comments in blue Stakeholder number (To be completed by the Agency) General comment (if any) Outcome (if applicable) (To be completed by the Agency) We welcome the Agency's initiative to revise the current CHMP guideline on medicinal products for the treatment of Alzheimer's disease (AD) and other dementias incorporating both the outcome of the workshop which took place at the EMA on 24-25 November 2014 and the most recent 1-1 meetings with applicants with experience on Scientific Advice on AD. EFPIA would encourage the Agency to maintain an open dialogue (e.g. workshops and discussion meetings) with companies active in this field in order to further support the drug development for such a high unmet medical need. There are three specific areas that would benefit from further round-table discussions or work-shops between the agency and companies: firstly: clinical meaningfulness and it measurement/demonstration; secondly use of biomarkers in general and for specific puroposes, as surrogates, predictive, prognostic value and inclusion of biomarker positive and negative patients in particular studies and thirdly, the use of MMRM. EFPIA agrees and appreciates the acknowledgement of AD as a “continuum with a long lasting presymptomatic phase” and encourages additional consideration of this diagnostic paradigm throughout the guideline We recognise that the draft AD guideline acknowledges the field is rapidly changing and common knowledge is being built, that the standardization and harmonization of the use of biomarkers for different purposes along the course of drug development needs further improvement, and that harmonization of the existing sets of clinical diagnostic criteria is needed. Therefore, we encourage 2/62
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Stakeholder number (To be completed by the Agency) General comment (if any) Outcome (if applicable) (To be completed by the Agency) the EMA to continue to facilitate the discussion with companies and scientific experts active in this field to build a common scientific position with regard to diagnostic criteria (e.g. through EMA workshops and other relevant discussion meetings such as EU AD Task Force, Alzheimer’s Association Roundtable). The specific aim of these discussions would be to identify the next
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