Press release
UPDATE: Lexicon Announces FDA Approval of INPEFA™ (sotagliflozin) for Treatment of Heart Failure
INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to placebo in the SOLOIST-WHF study Conference Call and Webcast on Tuesday, May 30, 2023, at 8:00 am Eastern Time A Media Snippet accompanying this announcement is available by clicking on the image or link below: PDF available: http://ml.globenewswire.com/Resource/Download/78db7a8c-bdce-44a2-80fb-a7d2be46305e THE WOODLANDS, Texas, June 15, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. 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 ortype 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The broad label encompasses heart failure 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. “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 is based on two randomized, double-blind, placebo-controlled Phase 3 cardiovascular outcomes studies of INPEFA in patients with heart failure or at risk of heart failure. Together, SOLOIST-WHF (Worsening Heart Failure) and SCORED enrolled almost 12,000 patients. Results from SOLOIST-WHF showed that INPEFA significantly reduced risk of the composite of hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death by 33% compared to placebo in patients who had been recently hospitalized for worsening heart failure. INPEFA is an inhibitor of both sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). The SGLT inhibitor class was recommended as first-line...