The US Food and Drug Administration (FDA) has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes.
The once-daily 20-mg oral sodium-glucose cotransporter 2 (SGLT2) inhibitor is indicated as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes, but not type 1 diabetes. It can be used in adults with an estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73m2.
Approval was based on results from 23 clinical trials withover 5000 participants, including more than 300 patients with stage 3 kidney disease (eGFR < 60 and > 30 mL/min/1.73 m2).
In the phase 3 studies, bexagliflozin significantly reduced A1c and fasting blood glucose at 24 weeks as monotherapyor as add-on to metformin and other glucose-lowering drugs and combinations. It also produced modest reductions in body weight and systolic blood pressure.
In the phase 3 Bexagliflozin Efficacy and Safety Trial (BEST) cardiovascular outcomes trial, the drug met its efficacy and safety objectives in patients at high cardiovascular risk. Noninferiority was demonstrated for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.
"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, Boston, in a press release from TheracosBio.
"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."
As with other SGLT2 inhibitors, adverse events seen in the trials include ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier's gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.
Bexagliflozin joins an already crowded field of SGLT2 inhibitors, some of which have been approved for additional cardiovascular and kidney indications.
Of interest, bexagliflozin was approved by the FDA for diabetes in catsin December 2022, as the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes not previously treated with insulin.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.
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FAQs
The FDA has approved bexaglifozin (Brenzavvy; TheracosBio), a once-daily, oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, for the treatment of adults with type 2 diabetes.
What is the new drug for type 2 diabetes helps with weight loss? ›
Zepbound is the latest diabetes drug approved for weight loss, joining Novo Nordisk's Wegovy, a high-dose version of its diabetes treatment Ozempic.
What is the new FDA approved drug for type 2 diabetes? ›
On May 13, 2022, the US Food and Drug Administration (FDA) approved a unique, first-in-class medication for the treatment of type 2 diabetes, known as tirzepatide (Mounjaro).
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In January 2024, the Medicines and Healthcare Products Regulatory Agency (MHRA) approved a multi-dose version of Mounjaro (tirzepatide) called Mounjaro Kwikpen to treat people with type 2 diabetes.
What are the benefits of taking bexagliflozin? ›
Therefore, in patients with type 2 diabetes mellitus (T2DM), bexagliflozin reduces blood glucose levels independently of insulin sensitivity. Aside from improving glycemic control, bexagliflozin may also reduce body weight, systolic blood pressure, and albuminuria.
What is the cost of bexagliflozin? ›
Oral Tablet
| Quantity | Per unit | Price |
|---|
| 30 | $11.50 | $345.03 |
| 90 | $11.29 | $1,016.09 |
Tracy Morgan, Dolores Cantina, Golnesa 'GG' Gharachedaghi: All have touted Ozempic, which the U.S. Food and Drug Administration approved in 2017 for the treatment of type 2 diabetes, as an effective weight loss tool.
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Kelly Clarkson underwent a notable weight loss transformation of 40 pounds, sparking rumors of drug use, but she achieved it through hard work. Going through a tough divorce from talent manager Brandon Blackstock, she focused on an organic approach, cutting sugar, carbs, and specific foods from her diet.
What is the best medicine to lower A1C? ›
FARXIGA can help with your first priority—lowering your A1C
FARXIGA is a once-daily pill proven to help lower A1C, along with diet and exercise. *Average reduction with 5mg + metformin XR when starting at 9.2% A1C. Metformin XR alone lowered A1C by 1.4% when starting at 9.1% A1C. Individual results may vary.
How is bexagliflozin different from other SGLT2? ›
While bexagliflozin has the same blood pressure-reducing effects as other, more commonly used SGLT-2 inhibitors, its cardiovascular safety profile in T2DM was also found favorable in a recent meta-analysis [52].
Several alternatives to metformin for Type 2 diabetes are available. Some medications, like SGLT2 inhibitors and GLP-1 agonists, also offer benefits for your heart, kidneys, and weight loss. Others, like insulin or Mounjaro, can be useful to add to metformin when you need stronger diabetes treatment.
Is there a new cure for type 2 diabetes? ›
Is there a cure for type 2 diabetes? There's no cure yet, but our scientists are working on a ground-breaking weight management study, to help people put their type 2 diabetes into remission. Remission is when blood glucose (or blood sugar) levels are in a normal range again.
What drink lowers blood sugar? ›
Drinking water regularly may rehydrate the blood, lower blood sugar levels, and reduce diabetes risk ( 20 , 21 ). Keep in mind that water and other zero-calorie drinks are best. Avoid sugar-sweetened options, as these can raise blood glucose, drive weight gain, and increase diabetes risk ( 22 , 23 ).
Why do doctors no longer recommend metformin? ›
However, the toll it takes on the digestive system may prevent many people with diabetes from taking it for more than a week or two. “Metformin commonly causes gastrointestinal symptoms such as diarrhea and flatulence,” explained a recent study published in the journal Diabetes, Obesity and Metabolism.
What is the new wonder drug for diabetes? ›
What is Ozempic used for? Ozempic is taken as once-weekly injection to manage blood glucose levels and HbA1c in people with type 2 diabetes. As a GLP-1 analogue medication, it increases the levels of incretins – a hormone – which helps your body to produce more insulin when needed.
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On December 2, 2021, the FDA approved rituximab (brand name Rituxan) in combination with chemotherapy for pediatric patients 6 months to 18 years with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.
What are the new sglt2 inhibitors approved? ›
Brenzavvy became the fifth SGLT-2 inhibitor approved in the US, after Invokana (canagliflozin), Farxiga (dapagliflozin), Jardiance (empagliflozin), and Steglatro (ertugliflozin).
How do you know if a medicine is FDA approved? ›
Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number. Look up the drug in the Orange Book or the biological product in the Purple Book.
