Study: BRENZAVVY® matches Dapagliflozin in Chinese type 2 diabetes

TheracosBio announced the publication of a study titled “Efficacy and safety of bexagliflozin compared with dapagliflozin as an adjunct to metformin in Chinese patients with type 2 diabetes mellitus: a 24-week, randomized, double-blind, active-controlled, phase 3 trial” in Journal of Diabetes.

BRENZAVVY® (bexagliflozin)

The study results demonstrated the noninferiority of BRENZAVVY® (bexagliflozin) to dapagliflozin, marketed as Farxiga in the United States, in patients with type 2 diabetes mellitus.

BRENZAVVY is an FDA-approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

The randomized, double-blind, active-controlled trial enrolled 406 patients with type 2 diabetes mellitus at sites in China. It successfully met its primary endpoint of noninferiority in HbA1c levels.

Systolic blood pressure also decreased from baseline to week 24 in patients treated with BRENZAVVY or dapagliflozin. The change in systolic blood pressure in the BRENZAVVY arm was -6.4 mm Hg whereas patients in the dapagliflozin arm observed a change of -6.3 mm Hg.

In addition to other measures of metabolic health, the study also assessed safety showing the number of patients that experienced adverse events was comparable between the BRENZAVVY and dapagliflozin arms.

“The results of the study comparing the clinical activity of two different medications within the same class of diabetes medications should be good news to all physicians, nurses, and pharmacists who manage type 2 diabetes in clinical practice.

The data demonstrates that Brenzavvy’s clinical activity is indistinguishable from the metabolic effects and safety of dapagliflozin, the most commonly prescribed diabetes medication in the same broad category of medications known as sodium-glucose cotransporter 2 inhibitors,” said J. Paul Lock, MD, co-author of the publication, medical monitor at TheracosBio, and endocrinologist at MetroWest Medical Center, Framingham, MA.

“In addition, healthcare professionals selecting effective medical resources for the treatment of individual patients will be buoyed by the availability of Brenzavvy as an effective and truly affordable alternative for diabetes management because of the favorable price structuring of Brenzavvy," Lock said. "This is a welcome event for real-world physicians.”

The study was performed by clinicians from several Chinese hospitals with guidance from researchers affiliated with TheracosBio and Newsoara Biopharma Co., Ltd., which has licensed bexagliflozin in China.

“It is important for patients with diabetes to have affordable treatment options such as BRENZAVVY to control their disease. We do not think that patients should have to compromise on efficacy or safety when they receive a more affordable option,” said TheracosBio CEO Brian Connelly. “This head-to-head study offers additional evidence that BRENZAVVY-treated patients with type 2 diabetes see metabolic outcomes similar to those with other SGLT2 inhibitors.”

In the United States, BRENZAVVY is sold at a simple, low cash-pay price through a network of pharmacies. Patients prescribed BRENZAVVY often do not have insurance, making the medicine affordable for those without insurance and, for those who are insured, BRENZAVVY avoids insurance-plan hurdles that impact the ability of patients to start and stay on therapy.

BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Phase 3 clinical studies have shown BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors or combinations of these agents. Although BRENZAVVY is not approved for weight or blood pressure reduction, modest decreases in both weight and blood pressure have been observed in the clinical program.

BRENZAVVY is available as 20 mg oral tablets recommended to be taken once daily, in the morning with or without food. BRENZAVVY is contraindicated in patients who are hypersensitive to bexagliflozin or any other ingredient in the BRENZAVVY tablet. The most common side effects of taking BRENZAVVY include female genital mycotic infections, urinary tract infections, and changes in urination, but more serious side effects are possible (see below, Important Safety Information about BRENZAVVY).

BRENZAVVY treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL/min/1.73 m2. Patients with eGFR between 30 and 59 mL/min/1.73 m2 are said to be in stage 3 chronic kidney disease. BRENZAVVY was the first SGLT2 inhibitor shown in a randomized, controlled clinical trial to be effective for glycemic control in adults with type 2 diabetes and stage 3 (3a + 3b) chronic kidney disease.

About TheracosBio:

TheracosBio develops novel therapeutics for diseases with significant societal impact. The mission of TheracosBio is to expand access to new medications for patients with common diseases.

For more information please visit https://www.brenzavvy.com

 

 

Contact the company, TheracosBio


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