KENILWORTH, N.J., Feb. 22 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today reported that the U.S. Food and Drug Administration (FDA) has granted a 6-month priority review to its New Drug Application (NDA) for NOXAFIL® (Posaconazole) Oral Suspension for use in preventing serious invasive fungal infections (IFIs) in high-risk patients. 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.
Schering-Plough is seeking U.S. 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 (HSCT) recipients or those with prolonged neutropenia.
Additionally, 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. OPC is a fungal infection of the mouth and throat caused by the yeast Candida and is often referred to informally as thrush.
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.
NOXAFIL is a broad-spectrum triazole antifungal agent discovered and developed by Schering-Plough Research Institute that exhibits potent activity in vitro against a wide range of fungal pathogens, including both moulds and yeasts.
Invasive fungal infections, which can be life threatening, most often occur in people who are immunocompromised or immunosuppressed, such as cancer patients undergoing chemotherapy or stem cell transplants.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the company's strategy and the development of NOXAFIL. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward- looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.
Source: Schering-Plough Corporation
