Schering-Plough Anti-Fungal Drug Recommended for Approval
Posted on: Monday, 25 September 2006, 21:00 CDT
The Committee for Medicinal Products for Human Use has issued a positive opinion on Schering-Plough's Noxafil product.
Noxafil is an oral suspension product for the prevention of fungal infections in patients who are at high risk of developing these infections.
The CHMP also recommended approval of Noxafil for oropharyngeal candidiasis (OPC) as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. OPC is a fungal infection of the mouth and throat.
Noxafil currently is approved in the European Union and Australia for the treatment of certain IFIs in adult patients with disease who are intolerant of certain commonly used antifungal agents.
"This CHMP recommendation demonstrates how prophylaxis with Noxafil has the potential to change medical practice in this area, offering physicians a well tolerated, effective option for preventing serious invasive fungal infections," said Oliver Cornely of the University of Cologne. "Invasive fungal infections are a leading cause of death in certain high-risk patient populations, so preventing these infections in the first place is critically important for these seriously ill patients."
The CHMP recommendation of Noxafil serves as the basis for a European Commission approval.
Source: Datamonitor
Related Articles
- No Disparities by Race/Ethnicity in Risk of AIDS and Death Among HIV-Infected Patients in Kaiser Permanente's Integrated Delivery System, Research Study Finds
- Nurses File Cal-OSHA Complaint After Hospital Refuses to Supply Swine Flu Masks for Units with Infected Patients
- CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors
- Aethlon Medical Reports Promising Treatment Results In Hepatitis-C Infected Patients
- Clinical Pharmacists Can Positively Contribute to Clinical Outcomes for HIV-Infected Patients
- Diagnostic Utility of Bone Marrow Sampling in HIV-Infected Patients Since the Advent of Highly Active Antiretroviral Therapy
- Serum Neopterin Levels in HIV Infected Patients With & Without Tuberculosis
- Phenytoin Hypersensitivity Syndrome Masquerading As Fever and Systemic Illness of Unknown Origin in an HIV-Infected Patient
- Treatment of Hepatitis C in HIV/Hepatitis C Co-Infected Patients: What is the Evidence?
- Metabolic Syndrome Among HIV-Infected Patients: Prevalence, Characteristics, and Related Factors
 |
 |
User Comments (0)
RSS Feeds