A six-month priority review is a significant acceleration of the standard review process for new drugs which takes ten months. Priority review 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.
Schering-Plough is seeking US marketing approval of Noxafil for prophylaxis of serious invasive fungal infections, including both moulds and yeasts, in patients who are at high risk of developing these infections, such as hematopoietic stem cell transplant recipients or those with prolonged neutropenia.
Additionally, the NDA also seeks marketing approval of Noxafil for the treatment of oropharyngeal candidiasis (OPC). Often referred to informally as thrush, OPC is a fungal infection of the mouth and throat caused by the yeast Candida. The FDA has accepted the drug in this indication for a standard ten-month review.
The company has filed a similar new drug application for Noxafil with the European Medicines Agency (EMEA). The product is currently approved in the European Union (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.