New SGLT2 inhibitor for Diabetes Type 2 | Brenzavvy

Medication Update

New SGLT2 inhibitor for Diabetes Type 2

On January 23, 2023, the FDA approved Brenzavvy (bexagliflozin) made by TheracosBio for the treatment of adults with type 2 diabetes.1 Brenzavvy is a SGLT2 inhibitor that lowers blood sugar by causing the removal of sugar from the body through urine.

Brenzavvy is available as 20 mg oral tablets and recommended to be taken once daily: in the morning with or without food. Like other SGLT2 inhibitors, Brenzavvy is given as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes.1-5 It can be used in adults with an estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73m2.1

Approval for Brenzavvy is based on results from 23 clinical trials of more than 5,000 adults with type 2 diabetes, including more than 300 patients with stage 3 kidney disease. Brenzavvy significantly reduced 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 of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors, or combinations of these agents.1 Although Brenzavvy is not approved for weight or blood pressure reduction, modest decreases in both weight and systolic blood pressure were observed. As with other SGLT2 inhibitors,1-5 adverse events seen in these studies included ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier's gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.

Bottom Line:

Brenzavvy joins a crowded list of SGLT2 inhibitor options approved in type 2 diabetes. These include:

  • Jardiance (empagliflozin)
  • Steglatro (ertugliflozin)
  • Invokana (canagliflozin)
  • Farxiga (dapagliflozin)

Among the SGLT2 inhibitors and because of their longer-term studies, Farxiga, Jardiance and Invokana carry additional indications in reducing risks of renal and/or cardiovascular disease.2-4 It will likely take several more years, but it is just a matter of time until Brenzavvy (and Steglatro) earn these additional indications.

Consideration is generally given to SGLT inhibitor products that have these additional benefits and are least costly. The annual treatment cost for a patient receiving a SGLT inhibitor can range from ~$4,146 - $7,218.

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References:

  1. Brenzavvy (bexagliflozin) prescribing TheracosBio, LLC. January 2023. Found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214373s000lbl.pdf. Accessed 02/04/2023.
  2. Jardiance prescribing Boehringer Ingelheim Pharmaceuticals, Inc. October 2022. Found at https://content.boehringer-ingelheim.com/DAM/7d9c411c-ec33-4f82-886f-af1e011f35bb/jardiance-us- pi.pdf. Accessed 02/04/2023.
  3. Invokana prescribing Janssen Pharmaceuticals. October 2022. Found at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing- information/INVOKANA-pi.pdf. Accessed 02/04/2023.
  4. Farxiga prescribing AstraZeneca Pharmaceuticals. January 2023. Found at: https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/0be9cb1b-3b33-41c7- bfc2-04c9f718e442/0be9cb1b-3b33-41c7-bfc2-04c9f718e442_viewable_rendition v.pdf Accessed 02/04/2023.
  5. Steglatro prescribing Merck and Company. 10/2022. Found at: https://www.merck.com/product/usa/pi_circulars/s/steglatro/steglatro_pi.pdf. Accessed 02/04/2023.