KENILWORTH, N.J., Jan. 31 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that its antifungal agent NOXAFIL(R) (posaconazole) Oral Suspension received an A-1 recommendation(1) (highest rating) for the prevention of invasive Aspergillus infections in certain high- risk patients in the latest Treatment of Aspergillosis: Clinical Practice Guidelines of the Infectious Diseases Society of America (IDSA) released this month. The recommendation pertains to the approved indication of NOXAFIL, in patients 13 years of age and older, for prophylaxis of invasive fungal infections (IFIs) due to Aspergillus in neutropenic patients with myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML), and hematopoietic stem cell transplant (HSCT) recipients with significant graft- versus-host disease GVHD.
NOXAFIL is the first and only antifungal approved for the prevention of IFIs caused by Aspergillus. NOXAFIL previously received a category 1 recommendation (highest rating) in the prevention of certain IFIs in high-risk cancer patients in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology,(2) issued in March 2007. Two landmark clinical studies demonstrating the efficacy of NOXAFIL prophylaxis were published in The New England Journal of Medicine in January 2007.(3,4)
IDSA Clinical Practice Guidelines are the recognized standard for clinical practice in the infectious diseases community and these latest guidelines are intended to summarize the current evidence for treatment of different forms of aspergillosis. Inclusion of NOXAFIL in the IDSA clinical practice guidelines continues to underscore the importance of mould-active antifungal prophylaxis in certain high-risk patients.
"The IDSA and NCCN recommendations, coupled with strong pivotal clinical data, highlight the importance of posaconazole prophylaxis as a key therapeutic strategy for the prevention of invasive Aspergillus infections in high-risk patients," said John Perfect, M.D., Professor, Department of Medicine, Division of Infectious Diseases, and Director, Duke University Mycology Research Unit. "We can prevent these infections from occurring, which is critical, because once they become established, they are extremely difficult to treat and the associated death rate is quite high."
Aspergillus species have emerged as a leading cause of life-threatening fungal infections in immunocompromised patients, an expanding high-risk patient population. More than 1.3 million hospital patients are affected by IFIs -- a number that continues to grow.(5) High-risk patients undergoing HSCT or chemotherapy for hematological malignancies who develop IFIs have a mortality rate ranging from 50-90 percent.(6)
About IDSA Clinical Practice Guidelines
The updated Treatment of Aspergillosis: Clinical Practice Guidelines of the Infectious Diseases Society of America are available on the IDSA Web site at: http://www.journals.uchicago.edu/doi/full/10.1086/525258.
IDSA practice guidelines are systematically developed statements to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances. Attributes of good guidelines include validity, reliability, reproducibility, clinical applicability, clinical flexibility, clarity, multidisciplinary process, review of evidence and documentation. Under the IDSA U.S. Public Health Service grading system for ranking recommendations in clinical guidelines, a strength of recommendation grade of "A" is defined as "good evidence to support a recommendation for use" and a quality of evidence grade of "1" is defined as "evidence from one or more properly randomized, controlled clinical trial."(7)
The U.S. Food and Drug Administration (FDA) approved NOXAFIL Oral Suspension in September 2006 for prophylaxis of IFIs due to Aspergillus and Candida in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
In October 2006, the FDA approved NOXAFIL Oral Suspension for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole. OPC is a fungal infection of the mouth and throat caused by the yeast Candida.
NOXAFIL Oral Suspension was approved in the European Union (EU) in October 2005 for use in treating certain serious IFIs in adult patients (18 years of age and older) with disease that is refractory to or who are intolerant of certain commonly used antifungal agents. In October 2006, NOXAFIL received EU marketing approval for prophylaxis of IFIs in the following adult patients at high risk of developing these infections: patients receiving remission-induction chemotherapy for AML or MDS expected to result in prolonged neutropenia and HSCT recipients who are undergoing high-dose immunosuppressive therapy for GVHD. NOXAFIL also was approved in the EU for treating OPC as first-line therapy in adult patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.
NOXAFIL Safety Information
The most common treatment-related serious adverse events (1% each) in the combined prophylaxis studies were bilirubinemia, increased hepatic enzymes, hepatocellular damage, nausea, and vomiting. In clinical trials, there were infrequent cases of hepatic reactions (e.g., mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin, and/or clinical hepatitis). Rarely, more severe hepatic reactions including cholestasis or hepatic failure including fatalities were reported in patients with serious underlying medical conditions (e.g., hematologic malignancies) during treatment with posaconazole. Liver function tests should be monitored at the start of and during the course of therapy. Discontinuation of NOXAFIL must be considered in patients who experience symptoms consistent with liver disease that may be attributable to NOXAFIL.
In the pooled prophylaxis safety analysis, fever, headache, anemia, diarrhea, nausea, vomiting, abdominal pain, hypokalemia, and thrombocytopenia were frequently reported treatment-emergent adverse events.
NOXAFIL has been shown to interact with several medications, including drugs that suppress the immune system, and these reactions may be serious. The product label should be consulted when other drugs are prescribed with NOXAFIL.
In clinical studies of OPC and refractory OPC, adverse events were reported more frequently in the pool of patients with refractory OPC. The most commonly reported serious adverse events in refractory OPC patients included fever (13%) and neutropenia (10%).
Coadministration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine, or quinidine, is contraindicated since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes. Coadministration with ergot alkaloids is also contraindicated.
Serious and rare fatal toxicity from cyclosporine has occurred when taken in combination with NOXAFIL and therefore reduction of the dose of drugs like cyclosporine, tacrolimus, or sirolimus and frequent monitoring of drug levels of these medications are necessary when taking them in combination with NOXAFIL.
The safety and effectiveness of NOXAFIL in patients below the age of 13 years old have not been established.
For NOXAFIL U.S. Prescribing Information please visit: http://www.spfiles.com/pinoxafil.pdf.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its 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 Private Securities Litigation Reform Act of 1995, including statements related to the potential market for 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, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in the company's third quarter 2007 10-Q.
(1) Category, Grade: Strength of recommendation: A - Good evidence to support a recommendation for use; Quality of evidence: 1 - Evidence from one or more properly randomized, controlled trial.
(2) NCCN Clinical Practice Guidelines in Oncology - v.1.2007. Prevention and Treatment of Cancer-Related Infections. http://www.nccn.org.
(3) Ullmann AJ, Lipton JH, Vesole DH, et al. Posaconazole or Fluconazole for Prophylaxis in Severe Graft-versus-Host Disease. New Engl J Med 2007; 356:335-47.
(4) Cornely OA, Maertens J, Winston DJ, et al. Posaconazole vs. Fluconazole or Itraconazole Prophylaxis in Patients with Neutropenia. New Engl J Med 2007; 356:348-59.
(5) Rapp RP. Changing strategies for the management of invasive fungal infections. Pharmacotherapy. 2004 Feb;24(2 Pt 2):4S-28S; quiz 29S-32S.
(6) Bow EJ, Laverdiere M, Lussier N, et al. Antifungal Prophylaxis for Severely Neutropenic Chemotherapy Recipients. Cancer 2002;94:3230-46.
(7) Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines, 1990.
|SOURCE Schering-Plough Corporation|
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