The FDA has scheduled a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee on October 31, 2024, to discuss the potential approval of Zynquista (sotagliflozin) for controlling glycemic levels in adults with type 1 diabetes and chronic kidney disease (CKD). This meeting is a significant step as the FDA has set a Prescription Drug User Fee Act (PDUFA) target date of December 20, 2024, for its decision on the drug.
Background on Sotagliflozin
Sotagliflozin, developed by Lexicon Pharmaceuticals, is a dual inhibitor of SGLT2 and SGLT1, which play critical roles in glucose regulation in the kidneys and gastrointestinal tract. The drug was initially submitted for approval to manage type 1 diabetes in 2019, but the FDA issued a complete response letter, indicating that the application required further data. Lexicon resubmitted the application in June 2024, hoping to gain approval for this specific indication.
Previous Approval and Clinical Data
Sotagliflozin was previously approved under the brand name Inpefa in May 2023 for reducing the risk of cardiovascular death and hospitalization due to heart failure in adults with heart failure, type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. The drug is available as a once-daily oral tablet, with a wholesale acquisition cost of $598 per month. For eligible patients, a $10 copay card is available, covering up to $2,600 in costs annually.
Data from the inTandem3 phase 3 trial, presented in March 2024, showed that sotagliflozin improved glycemic control in patients with type 1 diabetes and CKD. The trial found that adding 400 mg of sotagliflozin daily to insulin therapy resulted in significant reductions in A1C levels, body weight, and systolic blood pressure. Importantly, the safety profile, including risks of severe hypoglycemia, was similar between patients with CKD and those without the condition.
Future Developments
In addition to its use in diabetes and CKD, sotagliflozin is being studied in a phase 3 trial for treating hypertrophic cardiomyopathy (HCM), a condition affecting the heart’s left ventricle and impairing its ability to pump blood effectively.
Implications of FDA Approval
If approved for type 1 diabetes and CKD, Zynquista would mark Lexicon’s second major drug approval in two years, following Inpefa. This would significantly bolster the company’s commercial portfolio, as Inpefa generated $2.7 million in sales in the first half of 2024, making it the company’s sole revenue-generating product. The potential approval of Zynquista could lead to expanded treatment options for patients with type 1 diabetes and CKD, offering a novel approach to managing these chronic conditions.
The upcoming advisory committee meeting will be crucial in determining whether Zynquista will be approved for this new indication, potentially providing a new tool for clinicians managing type 1 diabetes and CKD.
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