US drug major Schering-Plough says that the Food and Drug Administration has approved its Noxafil product for the treatment of oropharyngeal candidiasis, including infections refractory to itraconazole and/or fluconazole.
Oropharyngeal candidiasis is a fungal infection of the mouth and throat caused by the yeast Candida and Noxafil (posaconazole) is a novel triazole antifungal agent originated by Schering-Plough.
This move follows the FDA's September 15 approval of Noxafil for the 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.
Patients at risk of this type of infection include haematopoietic stem cell transplant recipients with graft-versus-host-disease or those with haematologic malignancies with prolonged neutropenia from chemotherapy. Invasive fungal infections are a leading cause of death in these high-risk populations, with fatality rates of between 60% and 90% once they have taken hold.
A recent report by market research company Datamonitor suggested that the worldwide market for systemic antifungal drugs will grow from a level of around $3.3 billion 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.
Noxafil is well placed because it is the only antifungal agent approved for the prevention of invasive fungal infections caused by Aspergillus, an increasingly common pathogen
Noxafil, which was first introduced in Europe in November 2005, is one of a number of new antifungal agents that have reached or are nearing the market. In February, Pfizer got a green light in the USA for Eraxis (anidulafungin), while Astellas is scheduled to launch micafungin in 2007 and York Pharma is planning to introduce Abasol (abafungin) in the same year.
Pfizer used to dominate the antifungal market with its Diflucan (fluconazole) product, but since this lost patent protection it has now been supplanted by Merck & Co’s Cancidas (caspofungin), introduced in 2001, as the top systemic antifungal. Pfizer’s Diflucan follow-up Vfend (voriconazole) has seen its sales lag behind the leader.
Schering-Plough last month was granted a European Union positive opinion recommending approval of Noxafil for the prevention of invasive infections as well as for first-line treatment of oropharyngeal candidiasis.