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The first oral SGLT2 inhibitor approved by the FDA for treating diabetes in is now approved for humans with the disease, .

As an adjunct to diet and exercise, the oral treatment is indicated for adults with type 2 diabetes, and is not recommended for those with type 1 diabetes or for patients in diabetic ketoacidosis, according to the company.

Of note, the once-daily treatment can also be initiated in patients with stage 3 chronic kidney disease (CKD), a group where metformin is often avoided due to a risk of lactic acidosis.

Underpinning the approval were 23 clinical trials, which tested the agent in over 5,000 adults with type 2 diabetes. Phase III trials showed significant HbA1c and fasting glucose reductions by week 24 as monotherapy, in combination with metformin, or as an add-on to existing regimens containing sulfonylureas, metformin, insulin, and DPP-4 inhibitors. Trials also showed modest improvements in weight loss and systolic blood pressure while on treatment.

Bexagliflozin joins the growing list of SGLT2 inhibitors approved in type 2 diabetes, including empagliflozin (Jardiance), ertugliflozin (Steglatro), canagliflozin (Invokana), and dapagliflozin (Farxiga).

"As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes," Mason Freeman, MD, of Massachusetts General Hospital in Boston, said in a statement. "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."

In one of the supporting phase III trials involving patients with CKD, the drug elicited 0.31% and 0.43% drops in HbA1c for the stage 3a and stage 3b CKD subgroups, respectively. This 300-participant study also demonstrated significant improvements in body weight, systolic blood pressure, fasting plasma glucose, and albuminuria.

TheracosBio noted a higher incidence of lower-limb amputations compared with placebo in one trial involving type 2 diabetes patients with either established cardiovascular disease (CVD) or those at risk for CVD (8.3 vs 5.1 events per 1,000 patient-years). In total, 23 bexagliflozin-treated patients in the trial underwent amputations -- 15 of the toe and midfoot and eight above or below the knee.

Before starting treatment, "consider factors in the patient history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers," the company stated.

Other safety information included risks for ketoacidosis, volume depletion, urosepsis and pyelonephritis, hypoglycemia with concomitant use with insulin and insulin secretagogues, Fournier's gangrene, and genital mycotic infections.

Bexagliflozin comes in 20-mg oral tablets, to be taken once daily in the morning with or without food.

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