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FDA Approves SGLT2 Inhibitor Bexagliflozin to Treat Type 2 Diabetes in Adults


The US Food and Drug Administration announced today that it has approved bexagliflozin (Brenzavvy), a sodium glucose cotransporter-2 (SGLT2) inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D), according to a statement from manufacturer TheracosBio.

The approval is based on data from the bexagliflozin clinical program that evaluated the safety and efficacy of the antihyperglycemic agent in 23 trials comprising more than 5000 adults with T2D, including more than 300 patients with stage 3 kidney disease (eGFR <60 and >30 mL/min/1.73 m2).

In phase 3 trials, use of the SGLT2 inhibitor was associated with significantly reduced HbA1c and fasting plasma glucose at 24 weeks, as monotherapy, in combination with metformin, or as add-on pharmacotherapy to standard-of-care treatment comprising a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors, or combinations of these agents. Although not indicated for weight reduction or treatment of elevated blood pressure, bexagliflozin treatment resulted in modest decreases in both, according to TheracosBio.

In the phase 3 Bexagliflozin Efficacy and Safety Trial (BEST) cardiovascular outcomes trial completed in 2021, bexagliflozin met primary efficacy and safety endpoints in patients at high cardiovascular risk. Noninferiority was demonstrated for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.

“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, MD, director, Translational Research Center at Massachusetts General Hospital, in TheracoxBio announcement. ”Being involved in all of the clinical trials for BRENZAVVY, I am greatly impressed with the efficacy of the drug in reducing blood glucose levels and I believe it is an important addition to the SGLT2 inhibitor class of drugs.”

Bexagliflozin will be provided as 20 mg tablets to be taken once daily in the morning, with or without food. The SGLT2-inhibitor’s approved indication is for adult patients with T2D who have an eGFR >30 mL/min/1.73m2 and contraindicated in patients with end stage renal disease or who are receiving dialysis.

Today's FDA approval represents a significant milestone for TheracosBio and provides an important treatment option to patients who suffer from type 2 diabetes. We look forward to bringing BRENZAVVY to market,” said Albert R. Collinson, PhD, TheracosBio president and chief executive officer.

Adverse events seen in clinical trials with the class of SGLT2 inhibitors, including bexagliflozin, include ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier's gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.

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