TheracosBio, a Massachusetts-based pharmaceutical company, has gained U.S. Food and Drug Administration (FDA) approval for bexagliflozin, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor designed to improve glycemic control in adults with type 2 diabetes.
The newly approved medication, marketed under the name Brenzavvy, is available as 20 mg tablets that patients take once daily. It is indicated for patients with an estimated glomerular filtration rate greater than 30 mL/min/1.73 m2. Bexagliflozin is not recommended as a treatment for type 1 diabetes or diabetic ketoacidosis.
The FDA’s decision was based on data from 23 different clinical trials evaluating the safety and effectiveness of bexagliflozin. According to TheracosBio, the medication was associated with significant reductions in hemoglobin A1c and fasting blood sugar after 24 weeks of use. While some patients were treated with bexagliflozin on its own, others also took it metformin or other recommended medications.
While bexagliflozin is not approved for weight loss or reducing blood pressure, the company added, “modest decreases” have been seen in both areas among patients taking the medication.
“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, said in a prepared 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 its statement, TheracosBio emphasized that SGLT2 inhibitors have been associated with a heightened risk of ketoacidosis, a potentially fatal condition that requires immediate hospitalization. Patients showing signs of severe metabolic acidosis after taking bexagliflozin should be evaluated for ketoacidosis; if ketoacidosis is confirmed, the patient should stop taking bexagliflozin immediately.
In addition, the company added, bexagliflozin has been associated with a greater risk of lower limb amputation. Before prescribing bexagliflozin, clinicians should see if the patient has a history of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers or other conditions that suggest they face an above-average amputation risk.
The safety and efficacy of the drug was tested in the Bexagliflozin Efficacy and Safety Trial (BEST), which published results in 2021.
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