Schering-Plough Corporation has received a marketing approval from the European Commission for 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, maintains a company release.
"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. Noxafil provides the coverage needed to effectively treat difficult fungal infections requiring long-term therapy," said Raoul Herbrecht, professor and head of haematology in the department of haematology and oncology, University Hospital of Strasbourg, France.
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 authorisation with unified labelling that will be valid in the current 25 EU member states as well as in Iceland and Norway.
Noxafil is indicated for use in treating invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma and coccidioidomycosis in adult patients with refractory disease or who are intolerant of certain commonly used antifungal agents. It is a novel triazole agent that exhibits potent antifungal activity in vitro against a wide range of fungal pathogens, including both yeasts and moulds.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products.