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Lucy Chard
30 May 2023

Lexicon Pharmaceuticals gains FDA approval for heart failure drug

Lexicon Pharmaceuticals aiming to commercialise their recently approved heart failure drug in June, after receiving approval from the US FDA based on significant findings from two Phase III trials. 

The US FDA has now approved an oral tablet for the treatment of heart failure from Lexicon Pharmaceuticals. Sotagliflozin, under the brand name INPEFA™, is taken once a day, to help reduce the risk of death from a cardiovascular event, hospitalisation due to heart failure, and urgent heart failure visits in adults diagnosed with heart failure, type 2 diabetes mellitus, chronic kidney disease, and other conditions leading to a greater risk of cardiovascular disease. 

The approval covers a range of heart failure patients, including all of left ventricular ejection fraction (LVEF), and 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,” explained Lonnel Coats, Lexicon pharmaceutical’s Chief Executive Officer. “We expect this important innovation to be commercially available in the U.S. market by the end of June 2023.”

Sotagliflozin underwent the testing that eventually gained the approval in two randomised, double-blind, placebo-controlled Phase III clinical trials studying cardiovascular outcomes in patients who had heart failure or were at risk of heart failure, SOLOIST-WHF and SCORED. The trials included nearly 12,000 people. 

In the SOLOIST-WHF trial, the drug was shown to significantly reduce the number of hospitalisations and urgent visits for heart failure, and cardiovascular death by 33% compared to the placebo group. 

Sotagliflozin is part of the SGLT2 and SGLT1 class of inhibitors that are recommended for the treatment of heart failure by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) in their joint 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Experts from the associations decree that SGLT2 inhibitors in particular should be used in all patients with heart failure with preserved ejection fraction who are determined as stable during hospitalisation. 

“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,” stated Craig Granowitz, 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 hospitalisations.”

With this approval, Lexicon Pharmaceuticals hope that their treatment will be available for use by June 2023, with a comparable market pricing package for heart failure medications. 

Lucy Chard
Digital Editor - Pharma

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