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New IDSA Clinical Practice Guidelines Recommend NOXAFIL(R) (Posaconazole) For Antifungal Prophylaxis In Certain High Risk Patients
Schering-Plough
Corporation (NYSE: SGP) 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)
About NOXAFIL
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.
About Schering-Plough
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.
References:
(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.
Schering-Plough Corporation
http://www.schering-plough.com
View drug information on Noxafil.
New IDSA practici clinice liniile directoare recomanda NOXAFIL (R) (posaconazol) pentru profilaxia antifungice, în anumite pacienþii cu risc înalt - New IDSA Clinical Practice Guidelines Recommend NOXAFIL(R) (Posaconazole) For Antifungal Prophylaxis In Certain High Risk Patients - articole medicale engleza - startsanatate