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Announced on January 23, the US FDA's approval of bexagliflozin (Brenzavvy) was awarded to TheracosBio and indicates the SGLT2 inhibitor for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
The US Food and Drug Administration has approved bexagliflozin (Brenzavvy) for use an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to a statement from TheracosBio.
Announced on January 23, the SGLT2 inhibitor’s approval represents the second novel drug approved by the FDA in 2023 and is based on data from a clinical program boasting nearly 2 dozen trials with more than 5000 adults with type 2 diabetes.
“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 the aforementioned January 23 statement from TheracosBio. “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.”
Expected to be available in 20 mg oral tablets, with recommendations to be taken once daily in the morning with or without food, bexagliflozin represents the latest entry into a class that has dominated conversation as one of the most impactful advances in recent memories for cardiometabolic health. According to the indication from the US FDA, bexagliflozin can be initiated in adults with type 2 diabetes with an eGFR greater than 30 mL/min/1.73m2 and contraindicated in patients who are hypersensitive to bexagliflozin or any tablet ingredient and is not indicated for the treatment of type 2 diabetes in patients with end stage renal disease or who are receiving dialysis.
In their release, TheracosBio noted the clinical program used to assess the safety and efficacy of bexagliflozin included 23 clinical trials, with a combined population of more than 5000 adults with type 2 diabetes. In phase 3 trials, use of the SGLT2 inhibitor was associated with significantly reduced hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors, or combinations of these agents. The release also noted modest reductions in both weight and systolic blood pressure were observed in the clinical program, but the agent does not carry an indication for either of these.
“Today's FDA approval represents a significant milestone for TheracosBio and provides an important treatment option to patients who suffer from type 2 diabetes. We look forward to bringing BRENZAVVY to market,” said Albert R. Collinson, PhD, President and CEO of TheracosBio. “The approval of the BRENZAVVY NDA is a result of the tireless work of the TheracosBio team and investigators. I want to thank all of the patients who took part in our clinical trials.”