FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes
January 23, 2023 – TheracosBio has announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor.
Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m. It is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Patients with eGFR less than 60 and greater than 30 mL/min/1.73 m2
are said to be in stage 3 chronic kidney disease, and for these patients, metformin is often avoided due to the risk of lactic acidosis. Brenzavvy is contraindicated in patients who are hypersensitive to bexagliflozin or any tablet ingredient and is not indicated for the treatment of type 2 diabetes in patients with end stage renal disease or who are receiving dialysis.
The FDA approval is based on results from a clinical program that evaluated its safety and efficacy in 23 clinical trials, enrolling more than 5,000 adults with type 2 diabetes mellitus.
Although Brenzavvy is not approved for weight or blood pressure reduction, modest decreases in both weight and systolic blood pressure have been observed in the clinical program. Brenzavvy is available as 20 mg oral tablets recommended to be taken once daily, in the morning with or without food.
