FDA Approves New Drug for Type 2 Diabetes

The FDA has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Developed by TheracosBio, Brenzavvy is a SGLT2 inhibitor that is indicated to improve glycemic control in adults with type 2 diabetes. SGLT2 inhibitors are a class of prescription medicines that lower blood sugar by causing the kidneys to remove sugar from the body through urine.

According to the U.S. Centers for Disease Control and Prevention, more than 33 million Americans have type 2 diabetes.

Brenzavvy will be available as 20 mg oral tablets to be taken once daily. The details on its availability and pricing are still in development, a company spokesperson told Formulary Watch.

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

The FDA approval is based on results from a clinical program that evaluated the safety and efficacy in 23 clinical trials enrolling more than 5,000 adults with type 2 diabetes mellitus. In one phase 2 trial of 288 patients, Brenzavvy was found to be well-tolerated and provided a durable, clinically meaningful improvement in glycemic control over 96 weeks.

Phase 3 studies showed that Brenzavvy significantly reduced hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy and in combination with metformin. In one phase 3 trial that enrolled 426 patients, Brenzavvy was found noninferior to glimepiride, an oral antidiabetic, in lowering hemoglobin A1c and was associated with significantly fewer hypoglycemic events than glimepiride. In another phase 3 trial of 312 patients, bexagliflozin lowered hemoglobin A1c levels by 0.37% compared with placebo.

Although the therapy 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.

The most common adverse reactions were female mycotic infections, urinary tract infection and increased urination.