Efficacy, safety and cost of new drugs acting on the central nervous system.
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 One product received a negative opinion, and five had the application withdrawn before reaching the Committee decision.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.
Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157, Milan, Italy, garattini@marionegri.it; bertele@marionegri.it
Silvio
S
Garattini
Vittorio
V
Bertele'
D002491:Central Nervous System Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D017277:Drug Approval; D004345:Drug Industry; D005062:European Union; D006801:Humans
D002491:Central Nervous System Agents