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Germany says Komboglyze has 'no additional benefit'

February 16, 2013 1:30 AM UTC

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said in a preliminary benefit assessment that Type II diabetes drug Komboglyze saxagliptin/metformin from Bristol-Myers Squibb Co. (NYSE:BMY) and AstraZeneca plc (LSE:AZN; NYSE:AZN) provides "no additional benefit" over sulfonylurea in combination with metformin. The institute said the data AstraZeneca submitted were not suitable because the pharma compared Komboglyze with glipizide, a sulfonylurea that has not been marketed in Germany since 2007. IQWiG said AstraZeneca failed to show that glipizide was equivalent to glibenclamide or glimepiride, the marketed generic sulfonylureas which were requested as comparators by Germany's Federal Joint Committee (G-BA).

IQWiG also said Komboglyze plus insulin also provides "no additional benefit" over metformin plus human insulin -- the comparator requested by G-BA for Type II diabetics in whom insulin and metformin don't adequately control blood sugar levels. The institute said the data AstraZeneca submitted were not suitable because insulin was not administered in the studies according to current treatment guidelines. AstraZeneca said it would respond to IQWiG's assessment before the March 8 deadline. A final assessment from G-BA is expected in early May. ...