Schering-Plough Corporation has reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of NOXAFIL (posaconazole) Oral Suspension for prophylaxis (prevention) of invasive fungal infections (IFIs) in the following patients at high risk of developing these infections: patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD).
The CHMP also recommended approval of 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.
Noxafil currently is approved in the European Union (EU) and Australia for the treatment of certain IFIs in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents. Upon approval, the prophylaxis and OPC indications will expand the potential spectrum of use for Noxafil in the EU.
"This CHMP recommendation demonstrates how prophylaxis with Noxafil has the potential to change medical practice in this area, offering physicians a well tolerated, effective option for preventing serious invasive fungal infections," said Oliver Cornely, MD, University of Cologne, Germany. "Invasive fungal infections are a leading cause of death in certain high-risk patient populations, so preventing these infections in the first place is critically important for these seriously ill patients."
The CHMP recommendation of Noxafil serves as the basis for a European Commission approval. A Commission Decision will result in Marketing Authorization with unified labeling that will be valid in the current EU 25 member states as well as in Iceland and Norway.
The CHMP recommendation of Noxafil for prophylaxis is based primarily on the results of two successful head-to-head randomised clinical studies, the largest prophylaxis studies to date conducted in these high-risk patient populations. A total of more than 1,200 patients were enrolled in these studies. An open-label study compared Noxafil Oral Suspension 200 mg three times daily (n=304) to fluconazole suspension 400 mg once daily (n=240) or itraconazole oral solution 200 mg twice daily (n=58) as prophylaxis against IFIs in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS). A double-blind study compared NOXAFIL Oral Suspension 200 mg three times a day (n=301) to fluconazole capsules 400 mg once daily (n=299) as prophylaxis against IFIs in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease.
The CHMP recommendation of Noxafil for the treatment of OPC is based primarily on the results of a randomised, evaluator-blinded, controlled clinical study conducted in HIV-infected patients with azole-susceptible oropharyngeal candidiasis.