The Food and Drug Administration (FDA) has approved Brenzavvy™ (bexagliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Bexagliflozin is an oral sodium-glucose cotransporter 2 inhibitor. The approval was based on data from a clinical program that included 23 clinical trials enrolling more than 5000 adults with type 2 diabetes mellitus.
The efficacy and safety of bexagliflozin was evaluated as monotherapy (ClinicalTrials.gov Identifier: NCT02715258), in combination with metformin (ClinicalTrials.gov Identifier: NCT03259789), and vs glimepiride (ClinicalTrials.gov Identifier: NCT02769481) and sitagliptin (ClinicaTrials.gov Identifier: NCT03115112) as add-on therapy to metformin. Bexagliflozin was also studied in adults with type 2 diabetes mellitus with moderate renal impairment (ClinicalTrials.gov Identifier: NCT02836873), and in adults with type 2 diabetes mellitus with established cardiovascular disease (CVD) or at increased risk for CVD (ClinicalTrials.gov Identifier: NCT02558296).
Findings from these studies showed that treatment with bexagliflozin significantly reduced hemoglobin A1c compared with placebo. The efficacy of bexagliflozin was observed to be noninferior to glimepiride (titrated to a maximum dose of 6mg) and sitagliptin 100mg once daily.
Bexagliflozin was not found to be superior to placebo in reducing MACE (a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina). In a trial that included patients with type 2 diabetes and either established CVD or multiple risk factors for CVD, 10.1% (57/567) of the placebo group experienced 1 MACE event vs 7.9% (89/1132) of the bexagliflozin group.
As for safety, the most common adverse reactions reported were female genital mycotic infections, urinary tract infection and increased urination.
Brenzavvy is supplied as 20mg tablets in 30- and 90-count bottles.
- TheracosBio announces FDA approval of Brenzavvy™ (bexagliflozin) for the treatment of adults with type 2 diabetes. News release. TheracosBio. Accessed January 23, 2023. https://www.businesswire.com/news/home/20230123005126/en/TheracosBio-Announces-FDA-Approval-of-Brenzavvy%E2%84%A2-bexagliflozin-for-the-Treatment-of-Adults-with-Type-2-Diabetes.
- Brenzavvy. Package insert. TheracosBio; 2022. Accessed January 23, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214373s000lbl.pdf.