FDA Approves Bexagliflozin for Adults With Type 2 Diabetes

The oral SGLT2 inhibitor has been shown to reduce blood sugar and improve glycemic control as an adjunct to diet and exercise.

The FDA has approved bexaglifozin (Brenzavvy; TheracosBio), a once-daily, oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, for the treatment of adults with type 2 diabetes.

SGLT2 inhibitors are a class of prescription medications that lower blood sugar by causing the kidneys to remove sugar from the body through urine. Bexagliflozin is available as 20 mg oral tablets and is recommended to be taken once daily, in the morning with or without food.

The approval is based on results from a clinical program evaluating the safety and efficacy of bexagliflozin in 23 clinical trials with more than 5000 adults with type 2 diabetes. Phase 3 studies found that the treatment significantly reduced hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment with a variety of regimens, such as metformin, sulfonylureas, insulin, DPP4 inhibitors, or combinations of these agents.

Although it is not approved for weight or blood pressure reduction, modest decreases in both weight and systolic blood pressure were observed in the clinical program.

“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, MD, director of the Translational Research Center at Massachusetts General Hospital, in a press release. “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.”

Treatment with bexagliflozin can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2. Patients with an eGFR less than 60 and greater than 30 mL/min/1.73 m2 are classified as stage 3 chronic kidney disease, and often cannot take metformin due to the risk of lactic acidosis.

Bexagliflozin is not recommended for patients with type 2 diabetes or for the treatment of diabetic ketoacidosis. It is also not indicated for the treatment of type 2 diabetes in patients with end stage renal disease or who are receiving dialysis.

Reports of ketoacidosis have been identified in clinical trials and post-marketing surveillance in patients with type 1 or 2 diabetes who received SGLT2 inhibitors, including bexagliflozin. Patients receiving bexagliflozin who present with signs and symptoms of severe metabolic acidosis should be assessed for ketoacidosis regardless of blood glucose levels, because ketoacidosis associated with bexagliflozin may be present even if levels are less than 250 mg/dL.

In many of the reported cases of ketoacidosis, and particularly in patients with type 1 diabetes, the presence of ketoacidosis was not immediately recognized, and treatment was delayed because the presenting blood glucose levels were below those typically expected for diabetic ketoacidosis. Treatment may require insulin, fluid, and carbohydrate replacement.

“Today’s FDA approval represents a significant milestone for TheracosBio and provides an important treatment option to patients who suffer from type 2 diabetes,” said Albert R. Collinson, PhD, president and CEO of TheracosBio, in the press release. “We look forward to bringing Brenzavvy to market.”

REFERENCE

TheracosBio Announces FDA Approval of Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes. News release. BusinessWire; January 23, 2023. Accessed January 24, 2023. https://www.businesswire.com/news/home/20230123005126/en

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