Brenzavvy FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 12, 2023.
FDA Approved: Yes (First approved January 20, 2023)
Brand name: Brenzavvy
Generic name: bexagliflozin
Dosage form: Tablets
Company: TheracosBio, LLC
Treatment for: Diabetes, Type 2
Brenzavvy (bexagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- Brenzavvy works to reduce blood glucose levels by inhibiting SGLT2. Inhibiting SGLT2 reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion.
- Brenzavvy tablets are administered once daily in the morning.
- Brenzavvy is not recommended for use in patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis.
- Warnings and precautions associated with Brenzavvy include ketoacidosis, increased incidence of lower limb amputations, intravascular volume contraction, serious urinary tract infections including urosepsis and pyelonephritis, hypoglycemia, necrotizing fasciitis of the perineum, and increased risk of genital mycotic infections.
- Common adverse reactions include female genital mycotic infections, urinary tract infection and increased urination.
Development timeline for Brenzavvy
| Date | Article |
|---|---|
| Jan 23, 2023 | Approval FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes |
Further information
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