FDA approves combo pill for adults with type 2 diabetes

FDA has approved once-daily dapagliflozin and metformin hydrochloride extended-release (Xigduo XR, AstraZeneca) for the treatment of adults with type 2 diabetes. Xigduo XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

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The drug combines 2 antihyperglycemic agents with complementary mechanisms of action, dapagliflozin (Farxiga), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. It is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release.

SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.

 “The introduction of Xigduo XR represents the first of a flurry of new agents expected to be approved within the diabetes space over the next several months,” according to FormularyWatch Clinical Editor David Calabrese, RPh, MHP, vice president and chief pharmacy officer, Catamaran. 

“The combination of an SGLT-2 Inhibitor with metformin serves as yet another very clinically sensible option for the every growing number of type 2 diabetic patients striving to get to attain to improved and more consistent control over their disease,” Calabrese said.

The approval of Xigduo XR is based on 4 phase 3 clinical trials, which provided clinical evidence for the efficacy and safety of dapagliflozin and metformin IR or XR tablets in treatment-naïve patients, in patients inadequately controlled on metformin, as well as compared to a sulfonylurea (glipizide) plus metformin. There have been no clinical studies conducted with Xigduo XR combination tablets. Bioequivalence was demonstrated in healthy adults between Xigduo XR and dapagliflozin plus metformin XR as separate tablets.

Xigduo XR is approved with multiple dosage strengths of dapagliflozin and metformin HCl extended release, respectively, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg, and the starting dose should be individualized based on each patient’s current treatment regimen. Xigduo XR should be taken once daily in the morning with food with gradual dose escalation to reduce the risk of gastrointestinal side effects due to metformin. The maximum daily recommended dose is 10 mg for dapagliflozin and 2,000 mg for metformin HCl.

Diabetes is estimated to affect 29.1 million people in the United States and more than 382 million people worldwide. Prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90% to 95% of all cases of diagnosed diabetes in the United States.

Xigduo XR is already approved in Australia for the treatment of adults with type 2 diabetes, along with diet and exercise. Xigduo (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, is approved in the European Union.