On May 26, 2023, Lexicon Pharmaceuticals, Inc., announced the FDA approval of Inpefa (sotagliflozin), a once-daily oral tablet to decrease the risk of cardiovascular death, hospitalization for HF, and urgent HF visit in adults with HF or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

The broad label incorporates HF patients across the full range of left ventricular ejection fraction (LVEF), including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes.

Inpefa is classified as a dual inhibitor of both sodium-glucose cotransporter type 2 (SGLT2) and type 1 (SGLT1). Inhibiting SGLT2 diminishes renal reabsorption of glucose and sodium while inhibiting SGLT1 reduces intestinal absorption of glucose and sodium.

The SGLT inhibitor class was recommended as the first-line treatment for HF by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) in their joint 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

An April 2023 ACC expert consensus statement highlighted the benefit of SGLT inhibitors as part of Guideline-Directed Medical Therapy in patients with HF with preserved ejection fraction (HFpEF). According to the ACC expert consensus statement, SGLT2 inhibitors should be initiated in all individuals with HFpEF who are stable during hospitalization and have no patient population contraindications.

Lonnel Coats, Lexicon’s CEO, stated, “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 approval was based on data from the multicenter, randomized, double-blind, placebo-controlled phase III SOLOIST-WHF (Sotagliflozin on Cardiovascular Events in Participants with Type 2 Diabetes Post Worsening Heart Failure) and SCORED (Sotagliflozin on Cardiovascular and Renal Events in Participants with Type 2 Diabetes and Moderate Renal Impairment who are at Cardiovascular Risk) studies. Together, SOLOIST-WHF and SCORED enrolled almost 12,000 patients. The results from SOLOIST-WHF showed that Inpefa significantly diminished the risk of the composite of hospitalizations for HF, urgent visits for HF, and cardiovascular death by 33% compared with placebo in patients who had been recently hospitalized for worsening HF.

“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 VP and CMO. “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.”

Lexicon planned to set the medicine’s wholesale acquisition cost comparable to existing branded HF medications.

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