TheracosBio receives FDA OK for Brenzavvy
TheracosBio has received permission from the Food and Drug Administration for Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 inhibitor. Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. Brenzavvy is not recommended for patients with Type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, director of the Translational Research Center at Massachusetts General Hospital. “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.”
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“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 Collinson, 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.”
Brenzavvy is available as 20 mg oral tablets recommended to be taken once daily, in the morning with or without food.