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FDA Approves Inpefa as First Dual Heart Failure Medication

Inpefa (sotagliflozin) was recently approved by the FDA for heart failure. In trial results, sotagliflozin was shown to lower the risk of death and hospitalizations due to heart failure. 

Millions of American adults live with heart failure, and people with diabetes are two to four times more likely to develop the chronic condition.

Soon to hit the market is a new heart failure drug sotagliflozin (brand name Inpefa), which was approved by the FDA on May 26, 2023. A combination of SGLT-1 and SGLT-2 inhibitors, sotagliflozin is a dual drug shown in clinical trials to significantly reduce the risk of death and hospitalizations related to heart failure. Sotagliflozin was approved in Europe in 2019 under the brand Zynquista to treat type 1 diabetes in people with a body mass index of 27 or greater.

While the prescribing information for Inpefa, unlike other SGLT-2 inhibitors, does not explicitly recommend against use for people with type 1 diabetes, there is a warning for diabetic ketoacidosis, another serious diabetes complication. It also states that blood ketone monitoring should be considered in those with type 1 diabetes and others at risk for ketoacidosis.

Currently, SGLT-2 inhibitors including Jardiance (empagliflozin) and Farxiga (dapagliflozin) are prescribed to treat heart failure. Inpefa (sotagliflozin) is now approved for use in heart failure patients, with or without diabetes and regardless of heart function as measured by ejection fraction

Inpefa is also unique from other drugs like Jardiance and Farxiga because it has been studied in patients with worsening heart failure. Since it's being marketed as a heart failure medication, cardiologists may choose Inpefa over other SGLT-2 inhibitors, which are marketed as diabetes drugs.

The FDA's approval was based on the outcomes of two extensive phase 3 cardiovascular studies: SOLOIST-WHF and SCORED. Comprising nearly 12,000 patients with type 2 diabetes, the studies were randomized, double-blind clinical trials that assessed how effective sotagliflozin was in treating heart failure patients or those at risk of developing the condition.

Data from the SOLOIST-WHF trial demonstrated that Inpefa decreased the risk of heart failure, heart-related hospital visits, and cardiovascular mortality by 33% compared to a placebo. This finding holds particular significance for patients recently admitted to the hospital due to worsening heart failure.

Lexicon Pharmaceuticals, the manufacturer of sotagliflozin, is actively working towards making the drug available in the U.S. market by the end of June 2023. 

To learn more about SGLT-2 inhibitors and heart failure, read our other articles: