Regulatory Lexicon Pharma’s Heart Failure Drug Receives FDA Nod

Lexicon Pharma’s Heart Failure Drug Receives FDA Nod

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Sotagliflozin, a drug manufactured by Lexicon Pharmaceuticals (Lexicon) which is intended to treat heart failure, has been granted approval by the U.S. Food and Drug Administration (FDA).

The drug, branded under the name Inpefa, is to be used for the treatment of heart failure and the prevention of coronary risk factors like type 2 diabetes, chronic renal disease, hospitalization for heart failure and critical heart failure excursions.

Sotagliflozin now competes head-on with dapagliflozin (Farxiga) and empagliflozin (Jardiance), two SGLT2 inhibitors previously authorized for treating type 2 diabetes and preserving kidney function, as well as reducing the risk of hospitalization for heart failure in patients with the condition.

The agent is expected to go on sale in the country by the end of June 2023, according to a press statement from Lexicon. The approval is said to apply to a wide variety of patients with heart failure, including those with decreased and maintained left ventricular ejection fractions.

The spokespeople have also stated that the company will promote sotagliflozin with the aim of reducing the number of readmissions of patients who have been released from the hospital following an incident of severe cardiac decompensation.

The SOLOIST-WHF trial, which randomized 1222 individuals suffering from type 2 diabetes who were admitted to the hospital for deteriorating heart failure, revealed an impressive 33% drop in the number of deaths from cardiovascular diseases and hospitalizations and critical visits for heart failure. These findings serve as the foundation for this niche target for sotagliflozin.

Almost half of the patients included in the study took their first dosage while still in the hospital, while the other half took theirs a median of 2 days after being released. The drug seemed risk-free.

According to an abstract that was put forward at a conference in late 2022 but has not yet been peer-reviewed, treatment with sotagliflozin reduced the number of hospitalizations after both 30 and 90 days by approximately  50% when compared to the control group.

So far, the EMPULSE study, which randomized 530 individuals suffering from heart failure, is the only one to assess an SGLT2 inhibitor when launched in hospitalized patients. The main objective of EMPULSE was a composite mortality from any factor, the number of heart failure incidents, the amount of time before the initial heart failure event, or a deviation from baseline of 5 or more points in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at a period of 90 days. The study demonstrated that beginning an SGLT2 inhibitor in this environment was safe and culminated in a substantial clinical benefit.

In the DELIVER trial, which examined the effectiveness of dapagliflozin among individuals with heart failure and maintained ejection fraction, approximately 10% of patients began study therapy either during or after 30 days of heart failure hospitalization. In this category, dapagliflozin appeared to be as successful as it was in the remaining 90% of people who did not begin taking the drug during a severe or subacute phase of their condition.

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