Schering-Plough anti-fungal drug recommended for approval

Noxafil is an oral suspension product for the prevention of fungal infections in patients who are at high risk of developing these infections.

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 and Australia for the treatment of certain IFIs in adult patients with disease who are intolerant of certain commonly used antifungal agents.

“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 of the University of Cologne. “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.