Noxafil NDA Gets Priority Review

Schering-Plough’s NDA for Noxafil Oral Suspension (for use in preventing serious invasive fungal infections (IFIs) in high-risk patients) has been granted a six-month priority review by the FDA. Priority review designation is granted to drugs that, if approved, would be a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease.

The company is seeking U.S. marketing approval of Noxafil for prophylaxis of serious invasive fungal infections, including both molds and yeasts, in patients who are at high risk of developing these infections; such as hematopoietic stem cell transplant (HSCT) recipients or those with prolonged neutropenia. The NDA also seeks marketing approval of Noxafil for the treatment of oropharyngeal candidiasis (OPC), including refractory infections. This indication will receive a 10-month review by FDA.

The company has filed a similar new drug application for Noxafil with the European Medicines Agency (EMEA). The product is currently approved in the EU for the treatment of certain invasive fungal infections (IFIs) in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents.