EU Approves Schering-Plough’s Noxafil

Schering-Plough said Thursday the European Commission approved Noxafil for the prevention of invasive fungal infections in high-risk patients.

The specified patients include those receiving chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes and hematopoietic stem cell transplant recipients undergoing immunosuppressive therapy for graft versus host disease.

The European Commission also approved Noxafil for first-line therapy for oropharyngeal candidiasis in patients who have severe disease or are immunocompromised and who are expected to respond poorly to topical therapy.

With this approval, Noxafil is now approved in the European Union for both prophylaxis and treatment indications, broadening its utility to physicians as an important antifungal agent, said Robert Spiegel, Schering-Plough’s chief medical officer and senior vice president.

The approval of Noxafil for prophylaxis of invasive fungal infections in high-risk patients has the potential to change medical practice in this area, Dr. Oliver Cornely of the University of Cologne, Germany, and lead investigator of one of the pivotal clinical studies supporting the approval, said in a statement issued by Schering-Plough.