This article is more than 5 years old. Information may no longer be current.
FDA approves Xigduo XR to treat adults with type 2 diabetes
The FDA approved a formulation combining two antihyperglycemic agents in a once-daily extended-release tablet to treat adults with type 2 diabetes, according to a statement from the drug developer.
The combination of dapagliflozin (Farxiga, Bristol-Myers Squibb/Astrazeneca) and metformin hydrochloride extended release (Xigduo XR, AstraZeneca) is designed for use with diet and exercise to improve glycemic control.
“The approval of once-daily Xigduo XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.” Elisabeth Björk, head of cardiovascular and metabolism in global medicines development at AstraZeneca, said in the release.
The drug was approved with multiple dosage strengths of dapagliflozin and metformin hydrochloride extended release, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg, respectively, according to the release. The starting dose would be individualized based on a patient’s current treatment regimen.
The FDA approved the treatment after four phase 3 clinical trials in adults with type 2 diabetes offered evidence for the efficacy and safety in patients receiving no treatment and in those inadequately controlled on metformin immediate and extended release. The immediate-release formula is already approved in the European Union and the extended release in Australia.
The therapy is not recommended for patients with type 1 diabetes or diabetic ketoacidosis, according to the statement. The label contains a boxed warning for lactic acidosis, rarely occurring with metformin accumulation.
The treatment is contraindicated in patients with moderate to severe renal impairment, history of serious hypersensitivity to dapagliflozin or metformin hydrochloride or metabolic acidosis, including diabetic ketoacidosis, according to the release.
The most common adverse reactions have included female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea and headache, according to the statement.
Perspective
Back to Top
Patient compliance is of prime importance in treating patients with diabetes, especially in type 2 diabetics with their numerous disorders and multiple medications. Combination therapies, whereby the patients take two medications in one tablet has been demonstrated quite convincingly to improve compliance. The newly approved combination of dapagliflozin and metformin (Xigduo XR, AstraZeneca) is a major step in this direction. Both medications have different modes of action and therefore complement each other. Side-effect profiles of each are very minimal and well tolerated by the patients and should prove to be valuable in our treatment of many of our patients.