Novartis Plans Additional Data on Manufacturing Issues for Mycograb

November 30, 2006
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.

Basel, Switzerland (Nov. 17) -Novartis (www.novartis.com) plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (London, www.emea.eu.int) on manufacturing issues to support the approval of its antifungal drug “Mycograb.” The CHMP issued a negative recommendation for the drug.

The submission for European Union approval was made in 2005 by the UK biopharmaceutical company NeuTec Pharma, which Novartis acquired earlier this year. At the time of the acquisition, Novartis said that submission for marketing authorization for Mycograb in the United States was planned for 2009.

In issuing its negative vote, the CHMP concluded that there was insufficient data relating to the manufacturing and characterization of the product to determine the safety of the compound. Mycograb is a recombinant antibody fragment. It is produced through microbial fermentation and by third-party manufacturers.

Novartis is working with these manufacturers and the CHMP to provide further clarification and analysis.