US FDA approves Lexicon Pharma’s Inpefa for treatment of heart failure
Lexicon Pharmaceuticals, Inc. 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 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 US 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