Abstract
Objective
To examine the degree of innovation of the products with indications for CNS diseases approved for the European market through the centralized procedure.
Methods
This paper examines the documentation available on nine products approved by the European Medicines Evaluation Agency in its first years of activity.
Results
The Committee for Proprietary Medicinal Products approved only five products by consensus (levacetylmethadol, levetiracetam, olanzapine, pramipexole, riluzole). Four were approved by majority (entacapone, memantine, rivastigmine, zaleplon). One product received a negative opinion, and five had the application withdrawn before reaching the Committee decision.
Conclusions
An analysis of the efficacy and safety profile of these products indicates that few minor therapeutic advances have been achieved in this area. Most approved products cover needs already met, at higher cost, without substantial improvement.
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Acknowledgements
We are indebted to Mrs. Judy Baggott and the G.A. Pfeiffer Memorial Library Staff for helpful editorial assistance. S.G. and V.B. are, respectively, member and expert of the CPMP. The views presented in this paper are those of the authors and should not be understood or quoted as being made on behalf of the EMEA and/or its scientific committees. The works listed under "References" for each active substance refer to the EPAR on one brand product only, the first of those actually approved in alphabetical order. The web sites listed under "References" were last accessed on 11 September 2002.
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Garattini, S., Bertele', V. Efficacy, safety and cost of new drugs acting on the central nervous system. Eur J Clin Pharmacol 59, 79–84 (2003). https://doi.org/10.1007/s00228-003-0569-3
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DOI: https://doi.org/10.1007/s00228-003-0569-3