Schering-Plough Corporation (NYSE: SGP) reported that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL(R) (posaconazole) 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 is a novel triazole antifungal agent discovered and developed by Schering-Plough Research Institute.
This approval follows the Sept. 15 FDA approval of NOXAFIL for prophylaxis (prevention) of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Invasive fungal infections are a leading cause of death in these high-risk populations.
In the European Union (EU), the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on Sept. 21 issued a positive opinion recommending approval of NOXAFIL for the prophylaxis indication and for first-line treatment of OPC. These applications are currently pending a final European Commission decision. NOXAFIL is currently approved in the EU and Australia 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.
“We are pleased with the FDA approval of NOXAFIL for treating OPC,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “With this approval, we are bringing this important new medicine to more patients in need.”
The FDA approval of NOXAFIL for treating OPC is based primarily on the results of a randomized, controlled, evaluator-blinded clinical study in HIV- infected patients that compared NOXAFIL to fluconazole, as well as a non- comparative study of NOXAFIL in HIV-infected patients with OPC that was refractory to treatment with fluconazole or itraconazole.
NOXAFIL Safety Information
Clinical studies have demonstrated that NOXAFIL Oral Suspension is generally safe and well tolerated. The most common treatment-related serious adverse events (1 percent 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). Liver function tests (LFTs) should be monitored at the start of and during the course of therapy.
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.
Co-administration 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. Co- administration 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 is necessary when taking them in combination with NOXAFIL. The safety and effectiveness of NOXAFIL for prophylaxis in patients below the age of 13 years old have not been established.
Schering-Plough 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 32,000 people around the world. The company is based in Kenilworth, N.J.