AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Friday that approval by the US Food and Drug Administration (FDA) of Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).
Reportedly, this approval is based on two phase III trials, which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.
According to the company, in one trial, treatment with 5mg dapagliflozin/5mg saxagliptin in addition to metformin demonstrated statistically-significant decreases in HbA1c (average blood glucose levels), and an increase in the number of patients achieving the recommended HbA1c treatment goal of
Hims & Hers expands GLP-1 offering in Canada with generic semaglutide
Bayer's KERENDIA receives FDA priority review for type 1 diabetes and kidney disease treatment
Dexcom launches Dexcom Flex CGM system for Type 2 diabetes patients in Germany
Apotex announces commercial launch of Apo-Semaglutide Injection in Canada
Bayer to acquire Perfuse Therapeutics in USD2.45bn deal to expand ophthalmology pipeline
ZYUS Life Sciences receives second US pain management patent
Apotex receives Health Canada approval for a generic Ozempic equivalent
Cirius Therapeutics introduces gestational diabetes initiative
Boehringer Ingelheim's survodutide phase 3 data show significant weight loss in obesity trial
AOTI reports strong real-world outcomes for TWO2 wound therapy
Ascletis completes enrolment for US Phase II study of ASC30 in diabetes
Renalytix advances kidneyintelX.Dkd scale-up with laboratory expansion and CE submission
FDA expands approval of Sanofi's Tzield for early-stage type 1 diabetes in young children
EKF Diagnostics acquires Beep Insights technology to expand sports performance offering