FDA Approves Brenzavvy (bexagliflozin) for Type 2 Diabetes Glycemic Control
The FDA has approved Brenzavvy (bexagliflozin), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, for improving glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. The approval, announced January 20, 2023, adds a new option to the SGLT2 inhibitor class. Brenzavvy is not recommended for patients with type 1 diabetes. The recommended dose is 20 mg once daily, taken in the morning with or without food. Renal function should be assessed before initiation, and the drug is not recommended if eGFR is below 30 mL/min/1.73 m². Volume depletion should be corrected before starting therapy. The label includes data from six clinical trials, including monotherapy and combination therapy with metformin, as well as studies in patients with moderate renal impairment and those with established cardiovascular disease or at increased risk. In a 24-week monotherapy trial, bexagliflozin reduced HbA1c by 0.5% from a baseline of 8.1%, compared to a 0.1% reduction with placebo (difference -0.4%, 95% CI -0.6 to -0.1).
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Bexagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. It reduces renal glucose reabsorption, leading to increased urinary glucose excretion and lowered blood glucose levels.
Bexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
Recommended dose: 20 mg once daily, taken in the morning, with or without food. Do not crush or chew the tablet. Assess renal function before initiating and as clinically indicated. Correct volume depletion before initiating. Not recommended if eGFR less than 30 mL/min/1.73 m². Withhold for at least 3 days prior to major surgery or procedures associated with prolonged fasting; resume when patient is clinically stable and has resumed oral intake.
Bexagliflozin was studied as monotherapy (Trial 1) and in combination with metformin (Trials 2, 3, 4), in patients with moderate renal impairment (Trial 5), and in patients with established CVD or at increased risk (Trial 6). In Trial 1 (24-week, placebo-controlled monotherapy), bexagliflozin 20 mg reduced HbA1c by 0.5% from baseline 8.1% vs 0.1% reduction with placebo (difference -0.4%, 95% CI -0.6 to -0.1). Efficacy was noninferior to glimepiride and sitagliptin. Reductions in HbA1c were consistent across subgroups of age, sex, race, and geographic region.
Not recommended for type 1 diabetes mellitus. Assess renal function before initiation; not recommended if eGFR <30 mL/min/1.73 m². Correct volume depletion before starting. Withhold for at least 3 days prior to major surgery or procedures with prolonged fasting. See label for full warnings and precautions.
Bexagliflozin is a new SGLT2 inhibitor for type 2 diabetes. It provides an additional option for glycemic control as monotherapy or in combination with metformin. Its role is similar to other SGLT2 inhibitors, but specific cardiovascular or renal outcome data beyond glycemic efficacy are not detailed in this label.
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