Sotagliflozin Gets FDA Approval in HF Across EF Spectrum

The US Food and Drug Administration has approved sotagliflozin for the prevention of cardiovascular death, hospitalization for heart failure (HF), and urgent heart failure visits in adults with heart failure with or without diabetes. The labelling was granted across the “full range” of left ventricular ejection fraction, the manufacturer, Lexicon Pharmaceuticals, announced late last week.

The company intends to have the once-daily pill, which will have the brand name Inpefa, commercially available across the US by the end of June 2023.

The agency’s decision is based on the SCORED and SOLOIST-WHF trials, first released in 2020 at the American Heart Association Scientific Sessions, showing reductions in HF hospitalizations in diabetic patients with chronic kidney disease and in decompensated HF, respectively, with the benefits emerging after just a few months. Additional analyses confirmed a benefit across ejection fractions, including HF with preserved ejection fraction (HFpEF).

The drug enters a market already dominated by the sodium-glucose cotransporter 2 (SGLT2) inhibitors empagliflozin (Jardiance; Boehringer Ingelheim/Eli Lilly) and dapagliflozin (Farxiga; AstraZeneca), both of which now have labeled indications across the spectrum of LVEF. Of note, sotagliflozin is actually a dual inhibitor of SGLT1, the primary transporter for glucose absorption in the gut, and SGLT2, which reabsorbs glucose in the kidney.

Despite growing calls—and guideline recommendations—for SGLT2 inhibitors to be initiated as quickly as possible in HF, uptake has lagged, in part because of the high cost of the agents. Whether a third contender on the US market will help bring costs down remains to be seen.