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Sotagliflozin: First Global Approval.

Anthony Markham1, Susan J Keam2

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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Sotagliflozin, a dual SGLT inhibitor, effectively lowers HbA1c in type 1 diabetes patients but increases diabetic ketoacidosis risk. It received EU approval as an adjunct to insulin therapy.

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Area of Science:

  • Pharmacology
  • Endocrinology
  • Metabolic Diseases

Background:

  • Sotagliflozin is a novel dual inhibitor of sodium-glucose co-transporters (SGLT) 1 and 2.
  • It targets glucose absorption in the GI tract and reabsorption in the kidney.
  • Developed for type 1 (T1DM) and type 2 diabetes mellitus (T2DM).

Purpose of the Study:

  • To summarize the development milestones of sotagliflozin.
  • To highlight its recent EU approval as an adjunct to insulin in T1DM.
  • To discuss its efficacy and safety profile in T1DM patients.

Main Methods:

  • Review of the phase III inTandem clinical trial program.
  • Analysis of sotagliflozin's dual mechanism of action.
  • Summary of regulatory milestones in the EU and USA.

Main Results:

  • Sotagliflozin demonstrated a clinically meaningful reduction in HbA1c levels in T1DM patients.
  • An increased incidence of diabetic ketoacidosis was observed compared to placebo.
  • EU approval granted as an adjunct to insulin for T1DM patients with BMI ≥27 kg/m² and inadequate glycemic control.

Conclusions:

  • Sotagliflozin offers a new therapeutic option for specific T1DM patient populations.
  • Careful monitoring for diabetic ketoacidosis is crucial when using sotagliflozin.
  • Regulatory divergence between EU and USA highlights ongoing safety considerations.