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Lexicon Pharmaceuticals on May 26, 2023 announced that the US Food and Drug Administration (FDA) has approved INPEFA™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

  • heart failure or
  • type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

The broad label of INPEFA encompasses individuals with heart failure across a spectrum of left ventricular ejection fraction (LVEF), including preserved and reduced levels, regardless of diabetes status. This signifies a comprehensive approach to addressing the diverse needs of heart failure patients.

“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,” said Lonnel Coats, Lexicon’s chief executive officer. “We expect this important innovation to be commercially available in the U.S. market by the end of June 2023.”

The approval of INPEFA was a significant milestone for Lexicon Pharmaceuticals. It was supported by extensive research conducted in two large studies, SOLOIST-WHF and SCORED, involving nearly 12,000 participants. These studies were conducted with rigorous scientific methods, including randomization, double-blindness, and placebo control. The compelling results from SOLOIST-WHF demonstrated that INPEFA, acting as an inhibitor of both SGLT2 and SGLT1, significantly reduced the risk of adverse outcomes such as hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death by 33% compared to a placebo.

The recognition of SGLT inhibitors, including INPEFA, as a first-line treatment for heart failure by reputable organizations such as the AHA, ACC, and HFSA in their joint guideline reflects the growing importance of this class of medication. Furthermore, the expert consensus statement released by the ACC in April 2023 highlighted the benefits of SGLT inhibitors as part of Guideline-Directed Medical Therapy (GDMT) specifically for patients with heart failure with preserved ejection fraction (HFpEF). This signifies the potential of INPEFA to contribute to the management of HFpEF and reduce the burden of the condition.

Lexicon Pharmaceuticals is committed to making INPEFA readily available to patients, with an expected accessibility by the end of June 2023. The company aims to set the wholesale acquisition cost of the medication at a level similar to that of existing branded medications for heart failure, ensuring affordability and equitable access to this innovative treatment option.

“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, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “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.”

The approval of INPEFA, along with its broad label and the support it has garnered from clinical guidelines, highlights Lexicon’s dedication to transforming the lives of heart failure patients. The forthcoming availability of INPEFA signifies hope for improved outcomes and enhanced quality of life for individuals living with this condition.

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