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S-P's Noxafil Oral Suspension Approved in Europe
Posted on 2005-10-27 09:19:00
Schering-Plough Corporation today announced that the European Commission has granted marketing approval to Noxafil (posaconazole) oral suspension for the treatment of certain serious invasive fungal infections in adult patients with disease that is refractory to or who are intolerant of certain commonly used antifungal agents. The approval follows a positive opinion granted on July 27, 2005, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
In clinical studies, Noxafil has demonstrated broad-spectrum activity covering both yeasts and moulds responsible for serious invasive fungal infections. Invasive fungal infections, which can be life threatening, most often occur in people who are immunocompromised or immunosuppressed, such as organ transplant patients or cancer patients undergoing chemotherapy or stem cell transplant.
"With the approval of Noxafil, the European medical community now has a safe and effective option for treating patients with serious infections caused by a variety of fungal organisms, including those resistant to other therapies," said Raoul Herbrecht, M.D., professor and head of hematology in the Department of Hematology and Oncology, University Hospital of Strasbourg, France. "NOXAFIL provides the coverage needed to effectively treat difficult fungal infections requiring long-term therapy."
Approval of Noxafil in the European Union represents the first marketing approval for this novel antifungal agent discovered and developed by Schering- Plough Research Institute. The European Commission Decision results in Marketing Authorization with unified labeling that will be valid in the current 25 EU member states as well as in Iceland and Norway.
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