Lexicon Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Inpefa (sotagliflozin) to reduce the risk of cardiovascular death, and hospitalisation for heart failure.

Inpefa is an oral inhibitor of sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1), the two proteins responsible for glucose regulation.

It is administered as a once-daily oral tablet to treat heart failure, along with type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors in adults.

The indication includes a full range of left ventricular ejection fraction (LVEF), including preserved ejection fraction and reduced ejection fraction, for patients with or without diabetes.

Sotagliflozin has been evaluated in various clinical studies involving patient populations with heart failure, diabetes, and chronic kidney disease in about 20,000 patients.

Lexicon said that Inpefa is contraindicated in patients with hypersensitivity to the drug or any of its components and will be commercialised by the end of June 2023.

Lexicon chief executive officer Lonnel Coats said: “The approval of Inpefa along with the breadth of the label, is a major milestone in Lexicon’s path to fulfilling its mission of pioneering medicines that transform patients’ lives.

“We expect this important innovation to be commercially available in the U.S. market by the end of June 2023.”

The FDA approval is based on two Phase 3, randomized, double-blind, placebo-controlled cardiovascular outcomes studies of Inpefa.

The studies, dubbed SOLOIST-WHF (Worsening Heart Failure) and SCORED enrolled almost 12,000 patients with heart failure or at risk of heart failure.

In the SOLOIST-WHF trial, Inpefa significantly reduced the risk of composite hospitalisations for heart failure, and cardiovascular death by 33% compared to placebo.

According to the ACC expert consensus statement, SGLT2 inhibitors should be initiated in all individuals with HFpEF who are stable during hospitalisation, without any contraindications.

Lexicon senior vice president and chief medical officer Craig Granowitz said: “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.

“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 hospitalisations.”