Xigduo dapagliflozin/metformin regulatory update

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in an early benefit assessment that the added benefit of Type II diabetes drug Xigduo dapagliflozin/metformin from AstraZeneca is not proven because the manufacturer did not provide suitable data for any of the possible therapeutic indications. Xigduo is approved in the EU to treat Type II diabetes as an adjunct to diet and exercise to improve glycemic control in adult patients inadequately controlled by metformin alone; in combination with other glucose-lowering products, including insulin, in patients inadequately controlled with metformin and certain drugs; and in patients already being treated with dapagliflozin and metformin given as separate tablets.

Comments are due June 5, with a final assessment from G-BA expected in early August. Xigduo is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin. Dapagliflozin is approved to treat Type II diabetes in 40 countries, including those in the EU as Forxiga and in the U.S. as Farxiga. ...