FDA Approves New Type 2 Diabetes Drug Bexagliflozin

28 Jan 2023 • "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 with over 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 monotherapy or 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 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. Source: Medscape | Read full story"

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