Schering-Plough anti-infective put on regulatory fast track

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Schering-Plough anti-infective put on regulatory fast track

24th February 2006

http://www.pharmaceutical-business-review.com/article_news.asp?

guid=A82A4AB5-F3BA-474F-9380-8A31CE8F367A

By Staff Writer

The FDA has granted a priority six-month review to Schering-Plough's

new drug application for Noxafil oral suspension for use in

preventing serious invasive fungal infections in high-risk patients.

AdvertisementA six-month priority review is a significant

acceleration of the standard review process for new drugs which

takes ten months. Priority review is granted to drugs that, if

approved, would be a significant improvement compared to marketed

products in the treatment, diagnosis or prevention of a disease.

Schering-Plough is seeking US marketing approval of Noxafil for

prophylaxis of serious invasive fungal infections, including both

moulds and yeasts, in patients who are at high risk of developing

these infections, such as hematopoietic stem cell transplant

recipients or those with prolonged neutropenia.

Additionally, the NDA also seeks marketing approval of Noxafil for

the treatment of oropharyngeal candidiasis (OPC). Often referred to

informally as thrush, OPC is a fungal infection of the mouth and

throat caused by the yeast Candida. The FDA has accepted the drug in

this indication for a standard ten-month review.

The company has filed a similar new drug application for Noxafil

with the European Medicines Agency (EMEA). The product is currently

approved in the European Union (EU) for the treatment of certain

invasive fungal infections (IFIs) in adult patients with disease

that is refractory to or in patients who are intolerant of certain

commonly used antifungal agents.