(Galaxo Wellcome Press Release) - Glaxo Wellcome plc announces that the European Union's Committee for Proprietary Medicinal Products (CPMP) has recommended the approval of Agenerase (amprenavir), Glaxo Wellcome's first protease inhibitor (PI) for the treatment of HIV, in the 15 member states of the European Union. The CPMP's opinion will now be considered by the European Commission for a final decision.
The recommendation is for the use of Agenerase, in combination with other antiretroviral agents, for the treatment of PI-experienced HIV-infected adults and children above four years of age. Agenerase has a resistance profile different from that observed with other PIs and, unlike most currently marketed PIs, Agenerase has a twice-daily dosing regimen without any food or water restrictions.
The marketing application for Agenerase was submitted to the European Medicines Evaluation Agency (EMEA) in October1998 under the centralised procedure.
Agenerase is currently approved and marketed in Argentina, Brazil, Chile, Columbia, Israel, Mexico, Switzerland, Uruguay, and the USA. Amprenavir is also approved in Japan where it is marketed by Kissei pharmaceutical Co.
Glaxo Wellcome is a research-based company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and to healthcare providers who serve them.
Amprenavir was discovered by scientists at Vertex Pharmaceuticals of Cambridge, Massachusetts and licensed to Glaxo Wellcome in the United States, Europe, and other countries. Glaxo Wellcome has been responsible for product formulation and manufacture of Agenerase, design and implementation of clinical trials, and regulatory submissions.
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