TheracosBio’s oral drug approved by FDA for adults with type 2 diabetes
TheracosBio has announced that the first oral SGLT2 inhibitor, bexaglifozin, has been approved by the FDA for the treatment of adult patients with type 2 diabetes. The drug was originally indicated for cats with diabetes.
The once-daily treatment is recommended for adult patients with type 2 diabetes but is not indicated for those with type 1 diabetes or in diabetic ketoacidosis, however it can also be used for patients with stage 3 chronic kidney disease (CKD).
The approval follows 23 clinical trials, assessing the drug in over 5,000 patients with type 2 diabetes. The phase 3 trials showed significant HbA1c and fasting glucose reductions by the 24th week when used as a monotherapy, in combination with metformin, or as an additional treatment for those already being treated with sulfonylureas, metformin, insulin and DPP-4 inhibitors.
Mason Freeman MD, of Massachusetts General Hospital in Boston, US, commented: “As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes. 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.”
Pharmaceutical Industry news, analysis and insights