Lexicon Announces FDA Approval of INPEFA (sotagliflozin) for Treatment of Heart Failure - Seite 2

About 6.7 million Americans suffer from heart failure, with the prevalence expected to rise to 8.0 million by 2030. Heart failure is the leading cause of hospitalizations for individuals aged 65 and older, triggering approximately 1.3 million hospitalizations a year. Patients with heart failure are at highest risk of a heart failure event in the first 30 days post-discharge, with 7% dying and 25% being rehospitalized within one month.

“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.”

Lexicon expects INPEFA to be available by the end of June 2023. The company plans to set the medicine’s wholesale acquisition cost comparable to existing branded heart failure medications.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast Tuesday, May 30, 2023, at 8:00 am ET / 7:00 am CT. The dial-in number for the conference call is 888-317-6003 and the conference ID for all callers is 0516154. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.

About INPEFA (sotagliflozin)

Discovered using Lexicon’s unique approach to gene science, INPEFA (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.