The recommendation will form the basis for a European Commission approval, which will enable Noxafil to be marketed in the current 25 EU member states and in Iceland and Norway.
Approval of Noxafil would represent the first marketing approval for posaconazole, a triazole antifungal agent discovered and developed by Schering-Plough.
Invasive fungal infections, which can be life threatening, mostly occur in people who are immunocompromised or immunosuppressed, such as organ transplant patients or cancer patients undergoing either chemotherapy or stem cell transplant.
“A key challenge facing physicians in treating fungal infections today is finding effective treatment options when patients do not respond to or cannot tolerate initial therapy,” said Robert Spiegel, senior vice president of medical affairs at the Schering-Plough Research Institute. “Noxafil, upon approval, will provide a new therapeutic option for patients with serious infections caused by certain difficult-to-treat fungal organisms, including those refractory to other drugs.”
The approval recommendation, which was issued by the Committee for Medicinal Products for Human Use (CHMP), is based primarily on results from a clinical study that evaluated Noxafil for the treatment of invasive aspergillosis in patients with refractory disease or who were intolerant of other medicinal products. 42% of patients treated with the drug reported a successful response compared to 26% of patients in an external control group.