Page 29 - Pharma News Letter Vol1 Issue2 - Converted By Dr. Ahmed Rashed

Trends, insights, and news

Repurposing of a first dual SGLT 1/2 inhibitor

with a granted marketing approval

Sotagliflozin, a novel and first dual agent that Although the class of SGLT2 inhibitors is well
inhibits sodium-glucose cotransporter (SGLT) 1 known in the areas of HF, CKD, T2D, a therapy
as well as SGLT2, received marketing approval coming to market that also blocks SGLT1 is new.
from the US Food and Drug Administration This puts sotagliflozin in direct competition
(FDA) on May 26, 2023 for reducing the risk with two SGLT2 inhibitors, dapagliflozin and
for cardiovascular death, hospitalization for empagliflozin, that already have indications
heart failure (HF), and urgent HF visits in for preventing HF hospitalizations in patients
patients with HF, and also for preventing these with HF as well as approvals for T2D and
same events in patients with type 2 diabetes preservation of renal function.
(T2D), chronic kidney disease (CKD), and
other cardiovascular disease risk factors. References:
The approval was based on phase 3 results of
the SOLOIST-WHF trial, which randomized • Mitchel L. Zoler. FDA Approves New
1222 patients with T2D who had been recently Drug, Sotagliflozin, for Heart Failure.
hospitalized for worsening HF. The first dose of Available at: https://www.medscape.com/
the drug or placebo was administered just before viewarticle/992518#vp_3. Published on May
or just after hospital discharge, and patients were 26, 2023. Accessed on May 30, 2023.
followed for a median of nine months. Results • Allison Inserro. FDA Approves Sotagliflozin, a
showed that the rate of primary end point Dual SGLT1/2 Inhibitor, for Full Range of Heart
events ware lower in the sotagliflozin group Failure. Available at: https://www.ajmc.com/
than in the placebo group by 33%. In addition, view/fda-sotagliflozin-a-dual-sglt1-2-inhibitor-
sotagliflozin lowered the cardiovascular death for-full-range-of-heart-failure. Published on
rate and death rate from any cause by 16% May 27, 2023. Accessed on May 30, 2023.
and 18%, respectively, compared to placebo.
Some adverse events were more common with
sotagliflozin than with placebo (diarrhea and
severe hypoglycemia), but the percentage of
patients with hypotension and acute kidney
injury was similar for both groups.

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