The Food and Administration (FDA) has approved Inpefa™ (sotagliflozin) to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (HF), and urgent HF visit in adults with HF; or with type 2 diabetes mellitus, chronic kidney disease (CKD), and other CV risk factors.
Sotagliflozin is a sodium-glucose cotransporter type 2 (SGLT2) inhibitor that also inhibits SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium, while inhibiting SGLT1 reduces intestinal absorption of glucose and sodium.
The approval was based on data from the multicenter, randomized, double-blind, placebo-controlled phase 3 SOLOIST-WHF (ClinicalTrials.gov Identifier: NCT03521934) and SCORED (ClinicalTrials.gov Identifier: NCT03315143) studies.
SOLOIST-WHF evaluated the CV efficacy of sotagliflozin in 1222 hemodynamically stable adults with type 2 diabetes who had recently been hospitalized for worsening HF (median left ventricular ejection fraction was 35%). SCORED evaluated the CV efficacy of sotagliflozin in 10,584 adults with type 2 diabetes, CKD (estimated glomerular filtration rate of 25-60mL/min/1.73m2), and additional CV risk factors (eg, history of HF, obesity, dyslipidemia, hypertension, or elevated cardiac and inflammatory biomarkers).
Patients were randomly assigned to receive sotagliflozin or placebo orally once daily, in addition to standard of care. The primary endpoint for both studies was the total occurrence (first and potentially subsequent) of CV death, hospitalization for HF, and urgent HF visits after randomization.
In both trials, sotagliflozin was superior to placebo in reducing the primary composite endpoint. In SOLOIST-WHF, the number of primary endpoint events per 100 patient-years was 51.3 in the sotagliflozin arm and 76.4 in the placebo arm (hazard ratio [HR], 0.67; 95% CI, 0.53-0.85; P =.001). In SCORED, the number of primary endpoint events per 100 patient-years was 5.6 in the sotagliflozin arm and 7.5 in the placebo arm (HR, 0.75; 95% CI, 0.63-0.88; P <.001).
The most common adverse reactions reported were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.
Inpefa is supplied as 200mg and 400mg tablets in 30- and 90-count bottles. The product is expected to be available by the end of June 2023.
- Lexicon announces FDA approval of Inpefa™ (sotagliflozin) for treatment of heart failure. News release. Lexicon. May 26, 2023. Accessed May 30, 2023. https://www.globenewswire.com/news-release/2023/05/26/2677371/0/en/Lexicon-Announces-FDA-Approval-of-INPEFA-sotagliflozin-for-Treatment-of-Heart-Failure.html.
- Inpefa. Package insert. Lexicon; 2023. Accessed May 26, 2023. https://www.lexpharma.com/inpefa-US-PI.pdf.