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Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 2003
Author(s) -
Motola Domenico,
De Ponti Fabrizio,
Rossi Pasqualino,
Martini Nello,
Montanaro Nicola
Publication year - 2005
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2004.02320.x
Subject(s) - european union , medicine , therapeutic effect , therapeutic index , pharmacology , therapeutic approach , intensive care medicine , drug , business , international trade , disease
Since January 1995, all European Union applications for marketing approval for medicinal products derived from biotechnology and other drugs considered potentially innovative follow the EMEA centralized procedure. In order to assess the overall degree of therapeutic innovation of these drugs, we considered, for each approved agent, its target, the availability of previous treatments and the extent of its therapeutic effect. The following scores for therapeutic innovation were assigned through a consensus process: ‘A’ (important), ‘B’ (moderate) and ‘C’ (modest). The overall degree of important/moderate therapeutic innovation was 47% of all therapeutic agents (32% important; 15% moderate). Most (80%) of the EMEA‐approved therapeutic agents were for serious diseases. The remaining ones were for risk factors (7%) or nonserious diseases (13%).