Demographic Transition The Ageing of the population is an emerging and seemingly irrevocable trend, not only in Europe, but also in the US, Japan and China. The number of Europeans aged 65+ will almost double over the next 50 years, from 85 million in 2008 to 151 million in 2060, and the fastest growing segment is represented by the old-old (75-85 years old) and older old (85+) subjects.
The existence of regulatory gaps hampering innovative development in geriatric medicine has been acknowledged in the frame of the European Innovative Partnership on Active & Healthy Aging pilot project launched by the European Commission in 2011. Up to date Regulatory Authorities drew Industry’s attention to the scarcity of clinical efficacy and safety data obtained in geriatric subgroups, and questioned the acceptability of extrapolating data obtained on approved medicines in younger adults to the general, older population. Meanwhile no regulatory guidance and scarce regulatory discussion are providing insight on how to develop new medicines for conditions specific to older people, like sarcopenia in the context of physical frailty. For example, fighting sarcopenia, thereby improving muscle function, should translate in a decrease of major associated outcomes like falls and fractures. This project will give us the opportunity with Regulators, Academia and other stakeholders, to agree on the therapeutic indication, endpoints and Clinical Trial methodology which will allow to develop innovative treatments for this currently underdiagnosed geriatric condition. This will be the first non competitive interventional European clinical trial in frail sarcopenic older patients using physical activity as benchmark for future studies with investigational drugs.
The five-year project is the result of a rich multiple collaboration between sixteen major research institutions in the geriatric field across Europe: Università Cattolica del Sacro Cuore(lead), Le Centre Hospitalier Universitaire de Toulouse, Univerzita Karlova v Praze, Helsingin yliopisto, Servicio Madrileno de Salud , Universitaetsmedizin Goettingen, Georg-August-Universitaet - Stiftung Oeffentlichen Rechts , Université Paris Descartes , Università degli Studi di Firenze , Friedrich- Alexander- Universität Erlangen-Nürnberg , Uniwersytet Jagiellonski , Istituto Nazionale di Riposo e Cura per Anziani-INRCA ; small medium size companies: Caretek s.r.l., EU-Open S.R.l, Roessingh Research and Development ; and five EFPIA members: Sanofi(lead), GSK, Novartis, Servier and Lilly.