A little over a month after bexagliflozin’s approval to treat cats with diabetes, the drug has been cleared in humans.
Now christened Brenzavvy, bexagliflozin won a nod from the FDA to help improve glycemic control in adults with Type 2 diabetes, TheracosBio said Monday. The drug, which comes in 20-mg tablets, is taken once a day alongside diet and exercise.
The drug shouldn’t be used in Type 2 diabetes patients with end-stage renal disease on dialysis, TheracosBio stressed.
Back in December, bexagliflozin passed muster as the first oral therapy for cats with diabetes mellitus, with the FDA issuing a green light to Elanco Animal Health. Though the med carries “notable safety concerns” in cats, bexagliflozin holds the distinction of being the first sodium-glucose cotransporter 2 (SGLT2) inhibitor approved by the FDA for any animal species, the agency said late last year.
SGLT2 inhibitors help lower blood sugar by preventing the kidneys from reabsorbing sugar created by the body, which then leaves through the urine. The class has become a fixture in the treatment of Type 2 diabetes, where TheracosBio’s Brenzavvy will be forced to tussle with SGLT2 rivals like AstraZeneca’s Farxiga and Eli Lilly and Boehringer Ingelheim’s Jardiance.
The FDA based its approval on results from a whopping 23 trials investigating Brenzavvy in more than 5,000 Type 2 diabetes patients, TheracosBio said in a release. In phase 3 studies, Brenzavvy helped reduce patients’ hemoglobin A1c and fasting blood sugar after 24 weeks. Those benefits were seen whether Brenzavvy was given as a monotherapy, in combination with metformin or as an add-on to standard-of-care treatment comprising a range of regimens.
As with other SGLT2 meds, Brenzavvy—while not specifically approved for weight loss or blood pressure reduction—has the potential to help patients chart “modest decreases in both weight and systolic blood pressure,” TheracosBio said.
Elsewhere, the green light has likely caught the attention of Wanbang Biopharmaceuticals and Canadian biotech Sirona Biochem, which recently expanded a pact around Sirona’s SGLT2 inhibitor TFC-039.
Alongside its use in humans, Sirona is also exploring TFC-039’s potential as a diabetes and chronic kidney disease treatment in companion animals, thanks to SGLT2 inhibitors’ convenient oral dosing.