1st Cytoprotectant Set For EU Approval

The European Union's Committee for Proprietary Medicinal Products has recommended approval of Schering-Plough's selective cytoprotectant Ethyol (amifostine). It is the first drug of this type to be recommended for approval in Europe.

Nine of the 12 European Union countries backed the approval for amifostine, which is indicated to reduce the neutropenia-related risk of infection which is caused by the combination anticancer regimen, cyclophosphamide and cisplatin, in patients with advanced ovarian carcinoma. S-P expects that these nine countries will quickly follow the CPMP recommendation and approve the drug, probably within several months.

Schering-Plough has acquired exclusive rights to market amifostine in the EU and European Free Trade Association markets through an agreement with US Bioscience. Other agreements with US Bioscience have given S-P rights to market amifostine in a number of countries in Latin America and the Far East, as well as Eastern Europe, Australia, New Zealand, South Africa and certain Middle East countries.