IQWiG rebuffs Forxiga

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said in a preliminary benefit assessment that Type II diabetes drug Forxiga dapagliflozin from Bristol-Myers Squibb Co. (NYSE:BMY) and AstraZeneca plc (LSE:AZN; NYSE:AZN) provides "no additional benefit" vs. four sets of comparators requested by Germany's Federal Joint Committee (G-BA). The institute said the partners did not submit "suitable" data for the sodium-glucose cotransporter 2 (SGLT2) inhibitor, which was approved by the European Commission in November.

IQWiG said data indirectly comparing Forxiga as monotherapy vs. sulfonylurea were not suitable because the trials included patients who were tolerant to metformin; Forxiga is approved as monotherapy in the EU in patients who are intolerant to metformin. The institute said data indirectly comparing Forxiga plus insulin vs. metformin plus insulin were not suitable because insulin was not "sufficiently" optimized for individual patients, noting that patients for whom previous insulin therapy was not sufficient did not change insulin or dose. ...