Schering-Plough fungal treatment approved in EU

High-risk patients include those receiving chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes and hematopoietic stem cell transplant recipients. Invasive fungal infections most often occur in people who have compromised immune systems and are a leading cause of death in these high-risk populations.

“In patients with a compromised immune system, invasive fungal infections are very serious and can be difficult to treat once they’ve become established, so preventing these infections in the first place is critically important for these seriously ill patients,” aid Oliver Cornely, University of Cologne, Germany.

The European Commission also approved Noxafil for oropharyngeal candidiasis (OPC), as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. OPC is a fungal infection of the mouth and throat.

The Commission approval of these indications for Noxafil results in marketing authorization with unified labeling that is valid in the EU as well as in Iceland and Norway. Noxafil was previously approved in the EU and Australia for the treatment of certain invasive fungal infections in patients who are intolerant of certain commonly used antifungal agents.