Schering Plough’s Noxafil receives positive opinion from CHMP

Schering Plough has received a positive opinion for its Noxafil product, from the Committee for Medicinal Products for Human Use.

Noxafil is triazole antifungal agent for the prevention of invasive Aspergillus and Candida infections for children under the age of 13.

The CHMP has recommended approval of Noxafil for oropharyngeal candidiasis as first-line therapy for patients with severe disease or those with compromised immunity systems for those whose response to topical therapy is expected to be poor.

Recommendation of the product has been based on a trial of around 1,200 patients where Noxafil oral suspension was taken in comparison with fluconazole.

The company reports that the trials have shown Nofaxil oral suspension is “well tolerated” with infrequent cases of hepatic reactions.

Oliver Cornely, managing director of the University of Cologne, commented: “This CHMP recommendation demonstrates how prophylaxis with Noxafil has the potential to change medical practice in this area, offering physicians a well tolerated, effective option for preventing serious invasive fungal infections.”

Marketing authorisation for the drug will depend on approval from the European Commission, which in turn will be based upon the CHMP recommendation.

Recently, Schering Plough named Thomas Koestler as its new chief of research. Mr Koestler replaces Cecil Pickett who retires from the company.

The drugs manufacturer states that Pickett has gone on to become the new head of research for biotech company Biogen Idec.