Schering-Plough has been given the nod by the European Commission to market Noxafil (posaconazole) Oral Suspension, a new triazole antifungal agent for hard-to-treat infections. This is the first approval of the product worldwide, according to the company.
Noxafil has been cleared to treat serious, invasive fungal infections in adult patients who cannot be treated with first-line antifungal agents. The drug is expected to find particular use in the treatment of infections, such as aspergillosis, that are developing resistance to established treatments.
In clinical studies, Noxafil has demonstrated broad-spectrum activity covering both yeasts and moulds responsible for serious invasive fungal infections. In a Phase III study, a 400mg dose of the drug, given twice-daily, achieved a 42% clinical response rate in patients with invasive aspergillosis, compared to 26% response seen in a control group treated using other means [[25/10/05b]].
Invasive fungal infections, which can be life threatening, most often occur in people who are immunocompromised or immunosuppressed, such as organ transplant patients or cancer patients undergoing chemotherapy or stem cell transplant.
Raoul Herbrecht, professor and head of haematology at the University Hospital of Strasbourg, France, said: "Noxafil provides the coverage needed to effectively treat difficult fungal infections requiring long-term therapy."
A recent report by market research company Datamonitor suggested that the worldwide market for systemic antifungals will grow from a level of around $3.3 billion dollars in 2003 to almost $6 billion by 2014, driven by an increased incidence and severity of invasive fungal infections, combined with the launch of novel, premium priced antifungal products.