A combination oral tablet containing dapagliflozin and extended-release metformin was approved by the Food and Drug Administration for treating adults with type 2 diabetes, the manufacturer, AstraZeneca, announced on Oct. 30.
The dosage strengths approved include 5 mg and 10 mg of dapagliflozin with 500 mg or 1,000 mg of extended-release metformin. The approved indication is as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both dapagliflozin and metformin is appropriate.
This is the first product combing a sodium-glucose cotransporter 2 (SGLT2) inhibitor (dapagliflozin) with a biguanide (metformin) in one tablet administered once a day, the company said in a statement.
Approval was based on four phase III studies evaluating the drugs as combination therapy, but not with the actual combined tablet formulation, the statement said.
The FDA’s approval letter says that as part of its postmarketing requirements, the company should conduct a study evaluating whether pediatric patients with type 2 diabetes or healthy children aged 10-17 years can safely swallow the combination tablets. The letter also describes a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of dapagliflozin for the treatment of children and adolescents aged 10-17 years with type 2 diabetes as add-on therapy to metformin or as monotherapy, a required postmarketing study for the approval of dapagliflozin in January 2014.
AstraZeneca is marketing the combined product as Xigduo XR. It is also marketed in Australia under the same trade name. In the European Union, a combination of dapagliflozin and immediate-release metformin is marketed as Xigduo.