CHMP asks Novartis for more data on Mycograb, gives nod to Lucentis and Exforge

Swiss drug major Novartis has to submit additional information to the European Commission's Committee for Medicinal Products to support the approval of Mycograb 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 fungal and bacterial infections (Marketletter July 17). Novartis stressed that the CHMP's opinion relates to insufficient data on the manufacturing and characterization of the product to determine safety, and not to doubts about its efficacy. In separate news, the CHMP gave tentative approval to Novartis' Exforge (valsartan/amlodipine besylate) as a new treatment option for patients with high blood pressure, as well as Lucentis (ranibizumab), its treatment for wet age-related macular degeneration. The two drugs have combined potential annual sales of $1.0 billion, according to analysts.