Novartis announced today that it plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) in Europe to support the approval of Mycograb?, in development as a treatment for life-threatening fungal infections, after the CHMP issued a negative recommendation.
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.
The CHMP opinion was not linked to the efficacy of the compound. The Committee concluded that there was insufficient data relating to the manufacturing and characterization of the product to determine the safety of the compound. Novartis is committed to working with the CHMP to determine appropriate next steps.
Mycograb is a complex biological product produced through microbial fermentation and is produced by third party manufacturers. Novartis is working closely with these manufacturers and the CHMP 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, or “grab,” add-on treatment targeting heat shock protein 90 (“hsp90”) 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. Mycograb binds to the fungal hsp90, disabling the fungal defense mechanism and making fungi more susceptible to medicines such as amphotericin B. Mycograb has been granted Orphan Drug status in Europe and the US for use against invasive fungal infections, including invasive candidiasis.