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FDA approves Lexicon’s oral drug for heart failure, type 2 diabetes patients

Cytokinetics, a US-based biopharmaceutical company, announced the FDA had rejected its new drug application for approving a trial drug to treat heart problems with reduced ejection fraction (HFrEF).

HQ Team

May 27, 2023: Lexicon Pharmaceuticals, a Texas-based biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for its new oral tablet called Inpefa  (sotagliflozin).

This once-daily tablet is designed to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults who have heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

Lonnel Coats, the CEO of Lexicon Pharmaceuticals, said in a press release the company expects to make Inpefa commercially available in the U.S. market by the end of June 2023.

The FDA approval is based on two phase 3 clinical studies, known as SOLOIST-WHF and SCORED, which involved nearly 12,000 patients at risk of heart failure. The results of the SOLOIST-WHF study demonstrated that Inpefa reduced the risk of hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death by 33% compared to a placebo in patients who had recently been hospitalized for worsening heart failure.


INPEFA is an inhibitor of both sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). This class of SGLT inhibitors was recommended as a first-line treatment for heart failure by prominent medical associations such as the American Heart Association, the American College of Cardiology, and the Heart Failure Society of America. In April 2023, an expert consensus statement from the American College of Cardiology highlighted the benefits of SGLT inhibitors, including Inpefa, in patients with heart failure with preserved ejection fraction.

Cardiovascular diseases

Cardiovascular diseases are the leading cause of death globally, taking an estimated 17.9 million lives each year, according to the WHO. More than four out of five cardiovascular deaths are due to heart attacks and strokes, and one-third of these deaths occur prematurely in people under 70 years of age. Heart failure affects around 6.7 million Americans, and it is projected to increase to 8.0 million by 2030. It is the leading cause of hospitalizations among individuals aged 65 and older, resulting in approximately 1.3 million hospitalizations each year.

Patients with heart attacks are at the highest risk of experiencing heart failure events within the first 30 days after discharge, with 7% succumbing to it and 25% requiring readmission within one month.

Dr. Craig Granowitz, Lexicon’s Chief Medical Officer, stated that initiating treatment with Inpefa before or upon hospital discharge has the potential to reduce readmissions, benefiting patients, caregivers, healthcare providers, and health systems.

Lexicon Pharmaceuticals anticipates that Inpefa will cost at a level comparable to existing branded medications for heart failure.


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