Schering-Plough said today the European Commission had granted marketing approval for its Noxafil drug to treat oropharyngeal candidiasis, a fungal infection in the mouth, as well as for preventing invasive fungal infections.
Noxafil (posaconazole) debuted in Germany last November after being approved as a treatment for invasive fungal infections, and the new indications dramatically increase the potential patient population addressed by the product.
Specifically, Noxafil has been cleared in the EU for the prevention of invasive fungal infections in high-risk patients, including those whose immune systems are compromised by haematological cancers or immunosuppressive therapies, and as a first-line treatment for oropharyngeal candidiasis in patients who are immunocompromised or who have severe disease.
In the USA Noxafil is already cleared for the treatment and prevention of invasive fungal infections and for oropharyngeal candidiasis.
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.