The FDA approved bexagliflozin, an oral SGLT2 inhibitor, to improve glycemic control for adults with type 2 diabetes, according to a company press release.

The approval of bexagliflozin (Brenzavvy, TheracosBio) is based on results from 23 clinical trials evaluating the safety and efficacy of bexagliflozin with more than 5,000 adults with type 2 diabetes. These trials demonstrated a significant reduction in HbA1c and fasting blood glucose with bexagliflozin treatment after 24 weeks. This treatment can be utilized as a monotherapy or combined with metformin or as an add-on to standard-of-care treatment, including metformin, sulfonylureas, insulin, DPP-IV inhibitors or combinations of all these agents, according to the release.

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

Bexagliflozin is approved for adults with type 2 diabetes with an estimated glomerular filtration rate greater than 30 mL/min/1.73 m². Bexagliflozin is not recommended for patients with type 1 diabetes or for treating diabetic ketoacidosis.