Schering-Plough Noxafil antifungal NDA granted priority review by FDA

By Angela McDaniels

Seattle, Feb. 22 - Schering-Plough Corp. said the Food and Drug Administration has granted a six-month priority review to the company's New Drug Application for Noxafil (posaconazole) Oral Suspension antifungal.

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, according to a company news release.

Schering-Plough 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 recipients or those with prolonged neutropenia.

The application also seeks marketing approval of Noxafil for the treatment of oropharyngeal candidiasis, also known as thrush, including refractory infections. Schering-Plough said this indication will receive a 10-month review by FDA.

The company has filed a similar application for Noxafil with the European Medicines Agency.

Noxafil, a broad-spectrum trizole antifungal agent, is approved in the European Union for the treatment of certain invasive fungal infections in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents, according to the release.

Schering-Plough is a health care company based in Kenilworth, N.J., that produces prescription, consumer and animal health products.

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