Abstract
To assess the type and degree of innovation of the cardiovascular drugs centrally approved in the European Union between 1995 and 2002. Sources of information were the European Public Assessment Reports and the Summaries of Product Characteristics published by the European Medicines Evaluation Agency. The Agency approved 11 active substances belonging to 5 therapeutic classes: anti-hypertensives, anti-arrhythmics, anti-platelets, anti-coagulants and fibrinolytics. Analysis of the documentation on which the marketing authorisation was based shows few elements of innovation. Moreover, the new drugs usually cost more than similar drugs already available. Cardiovascular drugs approved in Europe in the last few years have contributed little to progress in this area. These approvals provide no real advantage to patients and lay an economic burden on society.
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We are indebted to Mrs Judy Baggott for helpful editorial assistance.
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S.G. and V.B., respectively, act as 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.
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Garattini, S., Bertele', V. Efficacy, safety and cost of new cardiovascular drugs: a survey. Eur J Clin Pharmacol 59, 701–706 (2003). https://doi.org/10.1007/s00228-003-0634-y
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DOI: https://doi.org/10.1007/s00228-003-0634-y