Schering-Plough said it has been granted a fast-track review in the USA for its antifungal product Noxafil, which debuted in Germany last November.
The US Food and Drug Administration (FDA) will now deliver a verdict on S-P’s application within six months of the filing date for Noxafil (posaconazole), rather than the normal 10-month review period.
The priority review designation is for the company's application to have the drug approved to prevent serious fungal infections in high-risk patients, including those with severely weakened immune systems.
S-P also has another application, to be ruled on within the standard 10-month time-frame, for the drug to be used to treat the oropharyngeal candidiasis.
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 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.