Komboglyze saxagliptin/metformin regulatory update

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 and AstraZeneca 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 also failed to show that glipizide was equivalent to two other marketed generic sulfonylureas - glibenclamide and glimepiride - which were requested as comparators by Germany's Federal Joint Committee (G-BA). AstraZeneca said it believes it showed equivalence of glipizide to G-BA's requested comparators.

IQWiG also said Komboglyze plus insulin also provides "no additional benefit" over metformin plus insulin - another comparator requested by G-BA. 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. ...