AZ Triple Combo Approved as Qternmet XR; Qtern Label Update

AstraZeneca announced FDA approval for its triple combination, Qternmet XR (dapagliflozin+saxagliptin+metformin XR), for improvement of glycemic control in patients with T2DM (Qternmet XR FDA label). Additionally, the Qtern label (dapagliflozin+saxagliptin) was updated with 3 notable changes: 1) eGFR cutoff lowered to 45ml/min/1.73m2 which is now consistent with Farxiga, 2) a new 5mg dapa/5mg saxa strength is now available, and 3) the indication no longer requires dapa failure or concurrent use of dapa and saxa. Below, FENIX provides thoughts on the new triple combination FDC and Qtern label updates.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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