Efficacy, safety and cost of new drugs acting on the central nervous system.

Abstract

To examine the degree of innovation of the products with indications for CNS diseases approved for the European market through the centralized procedure. This paper examines the documentation available on nine products approved by the European Medicines Evaluation Agency in its first years of activity. 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 One product received a negative opinion, and five had the application withdrawn before reaching the Committee decision. 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.