Neupogen Approved For SCN In USA

In the USA, Amgen's granulocyte colony stimulating factor product Neupogen (filgrastim) has been approved for its third indication, a potentially life-threatening blood disorder known as severe chronic neutropenia. It becomes the first agent to be approved for the disorder, which affects 1,000 to 2,000 children and adults in the USA.

Medical management of SCN to date has relied mainly on the episodic management of the frequent infections which are characteristic of the disorder, consisting principally of intermittent or continuous antibiotic use and hospitalization for severe episodes. There are both acquired and hereditary forms of the disease, and work is ongoing to identify the gene or genes involved.

In the Phase III trial carried out in the USA in support of the new indication, 120 patients with SCN were treated with filgrastim over a four-year period. Results show that treated patients experienced a 60% reduction in the incidence of infections as well as a 59% reduction in the incidence of required antibiotic use. The treatment was well-tolerated, with a high rate of compliance, and patients also reported increases in quality of life. SCN patients suffer frequent mouth ulcers, ear infections and periodontal disease. Amgen notes that 90% of the patients tested demonstrated complete or partial restoration of normal neutrophil levels.