Germany's IQWiG finds no added benefit for AstraZeneca and Bristol-Myers' Forxiga

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the new type 2 diabetes drug Forxiga (dapagliflozin) from AstraZeneca (LSE: AZN) and Bristol-Myers Squibb (NYSE: BMY), concluding that there was no added benefit over current standard therapy, because the drug manufacturer did not present any relevant data for any of the possible therapeutic indications of dapagliflozin.

The companies received approval for Forxiga from the European Commission last fall (The Pharma Letter November 15, 2012). Dapagliflozin is cleared both as monotherapy and in combination with other blood-glucose lowering drugs, including insulin. As monotherapy, it is an option for patients who do not tolerate metformin. Dapagliflozin can also be used as combination therapy, either together with metformin or with sulfonylureas if either of these two drugs alone is insufficient to control blood sugar. Dapagliflozin can also be combined with insulin if the target blood sugar levels cannot be achieved with insulin alone. Other combinations with oral antidiabetics are possible, but these were not presented by the manufacturer in its dossier.

G-BA specified appropriate comparator therapy