After a rocky development and regulatory road, the FDA has approved Sotagliflozin (Inpefa) for treating Heart Failure in patients with or without diabetes, manufacturer Lexicon Pharmaceuticals announced on Friday.

The dual SGLT1 and SGLT2 inhibitor is indicated for reducing the Risk of cardiovascular death and urgent visits or hospitalization for heart failure in adults with heart failure, type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.

Sotagliflozin thus joins SGLT2 inhibitors empagliflozin (Jardiance) and dapagliflozin (Farxiga) as guideline-recommended and FDA approved treatments for heart failure without limitations on left ventricular ejection fraction.

Lexicon said it plans to put the once-daily oral tablet on shelves by the end of June.

Approval for sotagliflozin was based on the SOLOIST-WHF and SCORED trials, which together showed an approximately 30% lower risk for the combined outcome of cardiovascular deaths and hospitalizations or urgent visits for heart failure in sotagliflozin recipients recently hospitalized for worsening heart failure (SOLOIST-WHF) and for those with type 2 diabetes, reduced kidney function, or risks for cardiovascular disease (SCORED).

“Based on outcomes observed in the SOLOIST-WHF study, initiating treatment with Inpefa prior to or upon hospital discharge has the potential to reduce the burden of readmissions on patients, caregivers, providers, and health systems,” said Craig Granowitz, MD, PhD, Lexicon’s senior vice president and chief medical officer, in a press release.

“With today’s FDA approval, Inpefa is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalizations,” said Granowitz.

Sotagliflozin inhibits two proteins involved in glucose regulation: SGLT2, responsible for glucose reabsorption by the kidney, and SGLT1, responsible for glucose absorption in the gastrointestinal tract.

The most commonly reported adverse reactions among sotagliflozin users have been urinary tract infection, volume depletion, diarrhea, and hypoglycemia.

The label for the dual SGLT1/SGLT2 inhibitor warns of the known risk for diabetic ketoacidosis, and suggests clinicians consider ketone monitoring for patients with type 1 diabetes (T1D) as well as others at risk.

Also flagged in the warnings and precautions are the risks for intravascular volume depletion, manifesting as symptomatic hypotension or acute transient changes in creatinine, which is particularly important for individuals with impaired renal function, elderly patients, and those on loop diuretics; Fournier’s gangrene; urosepsis and pyelonephritis; and genital mycotic infections.

Notably, a risk evaluation and mitigation strategy (REMS) program for diabetic ketoacidosis is not required as part of the approval. Such a program was suggested several years ago by some of FDA’s outside advisors when sotagliflozin was under review for T1D; the agency ultimately rejected the SGLT1/SGLT2 inhibitor for that indication in 2019.