Schering drug for prevention of invasive fungal infections gets FDA approval

Published: 25-Sep-2006
Regulatory

The US Food and Drug Administration (FDA) has approved manufacturer Schering-Plough's Noxafil (posaconazole) Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections.


The US Food and Drug Administration (FDA) has approved manufacturer Schering-Plough's Noxafil (posaconazole) Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections.

The treatment is designed for patients 13 years of age and older who are at a high risk of developing these infections due to being severely immunocompromised. For example, hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD), or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Noxafil is the first and only antifungal agent approved by FDA for the prevention of invasive fungal infections (IFIs) caused by Aspergillus species, Scher-ing says.

Patients undergoing hematopoietic stem cell transplant or chemotherapy for hematological malignancies such as acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) who develop IFIs have a high mortality rate.

The Noxafil approval is based on results of two large head-to-head randomised clinical studies. More than 1,200 patients were enrolled in these studies, which demonstrated substantially fewer breakthrough Aspergillus infections in these patients. In high-risk neutropenic patients, prophylaxis with Noxafil was associated with decreased all cause mortality.

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