FDA approves sotagliflozin to reduce risk for HF death, hospitalization
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Key takeaways:
- Sotagliflozin has received FDA approval to reduce risk for death, heart failure hospitalization and urgent HF visits.
- The approval covers patients with all forms of HF and those with certain CV risk factors.
The FDA has approved sotagliflozin, a dual SGLT1/SGLT2 inhibitor, for reduction of risk for death, HF hospitalization and urgent HF visits in patients with HF and in those with certain CV risk factors, Lexicon Pharmaceuticals announced.
Sotagliflozin (Inpefa), a once-daily tablet, is approved for two groups of patients:
patients with HF, regardless of diabetes status and ejection fraction; and
patients with diabetes, chronic kidney disease and other CV risk factors.
Sotagliflozin has the properties of an SGLT2 inhibitor by preventing glucose reabsorption in the kidney with the additional effect from SGLT1 inhibition of delaying glucose absorption in the gut, Deepak L. Bhatt, MD, MPH, Cardiology Today Intervention Section Editor, director of Mount Sinai Heart and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, told Healio. The drug was previously approved by the European Medicines Agency for use in people with type 1 diabetes; the FDA declined to approve a lower-dose version of sotagliflozin for use in type 1 diabetes in 2019, despite enthusiasm from the type 1 diabetes community at the time.
“The approval of sotagliflozin makes the SGLT inhibitor class a useful armamentarium in the care of HF patients, with demonstrated benefits of starting therapy quite early, while still in the hospital,” Bhatt said in an interview. “This approval could help close the gap that occurs right now with the use of SGLT2 inhibitors. There are already great data and labeling for empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) and dapagliflozin (Farxiga, AstraZeneca); however, there remains a significant rate of underutilization of SGLT2 inhibitors broadly as a class. Hopefully, having a third agent approved for use in HF will lead to greater uptake and even greater confidence in the benefits these drugs are providing across the full range of ejection fraction.”
The FDA approved the drug based on two randomized, double-blind, placebo-controlled, phase 3 CV outcomes studies of sotagliflozin in patients with HF or at risk for HF. The trials, SOLOIST-WHF and SCORED, enrolled nearly 12,000 patients combined.
For SOLOIST-WHF, researchers examined patients admitted to the hospital with acute decompensated HF who were initially stabilized and then randomly assigned sotagliflozin or placebo. The trial demonstrated a 33% reduction in risk for the composite endpoint of HF, urgent visits for HF and CV mortality for those who received sotagliflozin vs. placebo, with the benefits accruing very early after randomization and a number needed to treat of just 4, Bhatt said. The SCORED trial examined stable outpatients with type 2 diabetes and chronic kidney disease, considered at high CV risk. Researchers observed a 26% reduction in the same primary endpoint vs. placebo as well as an additional significant benefit in reduction of major adverse CV events for patients who received sotagliflozin, Bhatt said.
“In both trials, we saw a significant benefit across the full range of ejection fraction,” Bhatt said. “Further, there are strong data and reassurance that starting the appropriate patients with HF in the hospital is both safe and incrementally more effective than starting as outpatients. These data, with FDA labeling to support, will help move the needle and advance the care of HF patients.”
In a press release, Lonnel Coats, CEO of Lexicon, called the approval of sotagliflozin a “major milestone,” adding that the drug should be commercially available in the U.S. market by the end of June 2023.
For more information:
Deepak L. Bhatt, MD, MPH, can be reached at deepak.bhatt@mountsinai.org; Twitter: @dlbhattmd.
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