The U.S. Food and Drug Administration (FDA) has approved Brenzavvy (bexagliflozin) as the latest addition to the SGLT2 inhibitor class of type 2 diabetes drugs, according to a press release from TheracosBio, the maker of the new drug.
SGLT2 inhibitors are a class of type 2 diabetes drugs that have grown in popularity in recent years, and work by making the kidneys excrete excess glucose in urine. These drugs — which include canagliflozin (brand name Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) — are typically taken by mouth once daily to help control blood glucose levels, but they may also help protect against serious kidney problems and improve heart health in people who take them. In fact, Farxiga has been approved as a treatment for both chronic kidney disease and a common form of heart failure — regardless of diabetes status — following clinical trials involving people with these conditions. Unfortunately, research has shown that SGLT2 inhibitors are not prescribed as widely as they could be, and people with lower household incomes or belonging to certain racial or ethnic groups are less likely to receive them.
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Brenzavvy approved for adults with type 2 diabetes
According to the latest announcement, Brenzavvy is approved as an adjunct to diet and exercise for treating type 2 diabetes in adults, and is not recommended for people with kidney failure who are on dialysis. This approval was based on the results of 23 different clinical trials involving over 5,000 adults with type 2 diabetes. These study results showed that the drug was effective at reducing A1C (a measure of long-term blood glucose control) and fasting glucose levels after 24 weeks of treatment — taken either alone or in combination with metformin (the widely accepted first-line drug for type 2 diabetes), or when added to a variety of drug regimens involving metformin, sulfonylureas, insulin, or DPP-4 inhibitors.
“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 Boston, in the press release. “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.”
Brenzavvy is not recommended during the second or third trimesters of pregnancy, or for women who are breastfeeding. Because Brenzavvy helps lower blood glucose levels, if you’re currently taking insulin or a sulfonylurea, you may need to lower the dose of your current drug when you add Brenzavvy to your regimen to avoid hypoglycemia (low blood glucose). Talk to your doctor about how to safely add this drug, or any other diabetes drug, to your regimen without an undue risk for hypoglycemia.
Want to learn more about type 2 diabetes? Read “Diabetes Testing: Type 2 Diabetes,” “Type 2 Diabetes and a Healthy Family Lifestyle,” and “Welcome to Diabetes.”
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