AstraZeneca's Farxiga and Xigduo XR Receives FDA's Expanded Label Approval for Type 2 Diabetes (T2D) and Moderate Renal Impairment
Shots:
- The expanded label approval is based on P-III DERIVE study results assessing Farxiga (dapagliflozin 10 mg) vs PBO in patients with type 2 diabetes (T2D) with moderate renal impairment
- P-III DERIVE study results: reduction in HbA1c with safe results (-0.37% vs -0.03%)- reduced mean body weight (-3.17kg vs -1.92kg)- reduced mean fasting plasma glucose ((-21.46 mg/dL vs -4.87 mg/dL)- reduced mean systolic blood pressure (-4.8 mm Hg vs -1.7 mm Hg)
- Farxiga (dapagliflozin) is an SGLT2 inhibitor targeted as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus
Ref: Business Wire | Image: AstraZeneca
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