FDA Approves New SGLT-2 Inhibitor Brenzavvy
By Arvind Sommi
SGLT-2 inhibitors have been proven to reduce A1C and improve heart and kidney health, but these medications can be prohibitively expensive for many. The FDA’s approval of Brenzavvy (bexagliflozin) provides us hope for a more affordable SGLT-2 inhibitor.
The Food and Drug Administration approved a new medication for type 2 diabetes called Brenzavvy (bexagliflozin) on Jan. 23. This medication belongs to a class of drugs known as SGLT-2 inhibitors, which work by helping the body remove excess glucose (sugar) through the urine.
Brenzavvy was approved based on results from 23 clinical trials, which enrolled over 5,000 adults with type 2 diabetes. These trials showed that the medication, which was approved as the first oral treatment for diabetes in cats, effectively lowered blood sugar levels and improved overall diabetes control.
One of the most important trials was the BEST trial, a phase 3 trial that looked at the effects of Brenzavvy on A1C levels over a 24-week period. This trial enrolled 1,700 adults with type 2 diabetes and found that the once-daily medication was able to reduce A1C levels by 0.85% from an 8.3% baseline, indicating that on average, participants’ A1C levels went down from 8.3% to 7.45%.
A1C levels above 7% are associated with an increased risk of complications from diabetes, such as heart disease, kidney disease, and blindness. A reduction of 0.85% in A1C levels can significantly reduce the risk of these complications. Researchers also found participants taking Brenzavvy experienced a 3kg reduction in body weight after 48 weeks, and this weight loss was sustained during the 168 weeks of follow-ups.
Brenzavvy, which can be used alone or in combination with other diabetes medications, is not approved for people with type 1 diabetes. The most common side effect of Brenzavvy was yeast infections.
Brenzavvy is now the fifth SGLT-2 inhibitor approved in the US, along with Invokana (canagliflozin), Farxiga (dapagliflozin), Jardiance (empagliflozin), and Steglatro (ertugliflozin). Only 12% of adults with T2D in the United States are currently taking an SGLT-2 inhibitor, and among those who start, about 50% stop treatment within a year due to high cost and insurance barriers.
Learn more about SGLT-2 inhibitor medications: