EU voices concerns over Novartis fungal drug

This submission for European Union approval was made in 2005 by the UK biopharmaceuticals company NeuTec Pharma, which Novartis acquired in mid-2006 to expand its portfolio of compounds for hospital-acquired fungal and bacterial infections.

Mycograb is produced by third party manufacturers. Novartis said it is working closely with these manufacturers to provide further clarification and analyses and is confident of gaining regulatory approval. Mycograb had not been submitted for approval in any other country.

Mycograb is a twice-daily intravenous genetically recombinant antibody fragment developed for treatment of invasive candidiasis. This life-threatening fungal infection, which is due to the candida species, has a high mortality rate.

In clinical trials, the combination of Mycograb plus amphotericin B demonstrated clear superiority over amphotericin B monotherapy, considered the standard of care.