The new medication reduces HbA1c and improves glycemic control as an adjunct to diet and exercise.
The FDA has approved bexagliflozin (Brenzavvy), a once-daily, oral, sodium-glucose cotransporter 2 (SGLT2) inhibitor as an adjunct therapy to diet and exercise for the improvement of glycemic control in adults with type 2 diabetes, according to a news release.1
According to manufacturer TheracosBio, the FDA approval is based on results of a clinical program evaluating the safety and efficacy of bexagliflozin in 23 clinical trials and a cohort of more than 5000 adults with type 2 diabetes. Phase 3 study results in particular showed that bexaglifloxin significantly reduced both hemoglobin A1c (HbA1c) and fasting blood sugar after 24 weeks, regardless of administration as a monotherapy, in combination with metformin, or as an add-on to standard of care treatment regimens. Modest decreases in both weight and systolic blood pressure were also noted, although bexagliflozin is not approved for either weight or blood pressure reduction, per the press release.1
“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 Boston. “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 is not indicated for the treatment of type 2 diabetes in patients with end stage renal disease, or in patients who are receiving dialysis. Treatment can be initiated in adults with type 2 diabetes who have an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73m2.