title: Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 2003.
abstract: 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%).
authors.affiliation: Department of Pharmacology and Interuniversity Research Centre for Pharmacoepidemiology, University of Bologna, Bologna, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Motola
authors.forename: Fabrizio
authors.initials: F
authors.lastname: De Ponti
authors.forename: Pasqualino
authors.initials: P
authors.lastname: Rossi
authors.forename: Nello
authors.initials: N
authors.lastname: Martini
authors.forename: Nicola
authors.initials: N
authors.lastname: Montanaro
mesh_terms: D017277:Drug Approval; D005062:European Union; D012189:Retrospective Studies; D013678:Technology, Pharmaceutical