Nicole DeFeudis
Editor

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

The company did not release Inpefa’s price but said it will be “comparable to existing branded heart failure medications.” Lexicon CEO Lonnel Coats expects the drug to hit the market by the end of June.
“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,” Coats said in a news release.

The company’s stock was up about 7% in after-hours trading on Friday.

Regulators based their decision on results from two Phase III trials, including the SOLOIST-WHF study in which sotagliflozin reduced the risk of the composite of cardiovascular death and heart failure-related hospitalization and urgent visits by 33% compared to placebo in patients who had been recently hospitalized for worsening heart failure, according to Lexicon.

Lexicon once touted sotagliflozin as a promising option for diabetes, leading Sanofi to put down $300 million upfront in 2015 in a deal worth up to $1.7 billion including milestones. But months after the FDA rejected the treatment in diabetes in 2019, Sanofi terminated the deal, shelling out $260 million to do so. In a rare explanation of the complete response letter, regulators said the data “demonstrated that the addition of sotagliflozin to insulin is associated with an increased risk of diabetic ketoacidosis, a serious and often life-threatening consequence of insulin insufficiency.”

Flying solo, Lexicon filed a new drug application in late 2021 for sotagliflozin in heart failure. Then, a few months later, the company withdrew the submission “to correct a technical issue with the submission recently identified by the company.”

It refiled in July, announcing at the time that it expected to bring the new treatment to market by the middle of 2023. It unveiled a disease awareness campaign, called “Into the Dark,” at the American College of Cardiology’s annual meeting earlier this year that targeted healthcare professionals who treat heart failure patients in the hospital. The campaign noted that about 25% of heart failure patients are readmitted within a month after discharge, and an estimated 7% die during that first month.

Jefferies analysts last month estimated the drug could bring in $350 million in peak sales.