FDA approves sotagliflozin, the new heart failure drug from Lexicon Pharmaceuticals
Sotagliflozin has been approved by the U.S. Food and Drug Administration (FDA) as a daily treatment to reduce the risk of cardiovascular death, hospitalization for heart failure or urgent heart failure visits among patients with heart failure or cardiovascular risk factors such as type 2 diabetes and chronic kidney disease.
Sotagliflozin, developed by Texas-based Lexicon Pharmaceuticals, will be marketed under the name Inpefa. It is expected to be commercially available by the end of June 2023.
The FDA based its decision in part on data from two randomized trials—SOLOIST-WHF and SCORED—focused on the safety and effectiveness of sotagliflozin. Nearly 12,000 patients were enrolled in the two studies, and results from both were published in full in the New England Journal of Medicine. Click here to read the SOLOIST-WHF findings and here to read the SCORED findings.
“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,” Craig Granowitz, MD, PhD, senior vice president and chief medical officer of Lexicon Pharmaceuticals, said in a prepared statement. “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 the breadth of the label, is a major milestone in Lexicon’s path to fulfilling its mission of pioneering medicines that transform patients’ lives,” added Lonnel Coats, the company’s CEO.
Unlike other heart failure medications on the market, including SGLT2 inhibitors empagliflozin and dapagliflozin, sotagliflozin is a dual SGLT1 and SGLT2 inhibitor.
Additional information about sotagliflozin, including its development and potential to boost patient outcomes, is available in this February interview with Bertram Pitt, MD.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.