FDA Advisory Committee Rejects Sotagliflozin for Type 1 Diabetes and CKD
Key Insights
An FDA advisory committee has voted against approving Lexicon's sotagliflozin for treating type 1 diabetes (search) and chronic kidney disease (search) (CKD (search)).
This marks the second time in five years that an FDA committee has not endorsed the benefit-risk profile of sotagliflozin.
The committee's decision raises concerns about the drug's safety and efficacy profile in the target patient population.
An FDA advisory committee has voted against recommending approval for Lexicon Pharmaceuticals' sotagliflozin for the treatment of type 1 diabetes (search) and chronic kidney disease (search) (CKD (search)). This is the second time in five years that the drug has faced rejection from an FDA advisory group, casting doubt on its potential to reach the market for this indication.
The Endocrinologic and Metabolic Drugs Advisory Committee reviewed the available data on sotagliflozin, focusing on its efficacy in managing blood sugar levels and reducing the risk of cardiovascular events in patients with type 1 diabetes (search) and CKD (search). However, concerns regarding the drug's safety profile, specifically the risk of diabetic ketoacidosis (search) (DKA (search)), appeared to weigh heavily on the committee's decision.
The FDA will now consider the advisory committee's recommendation as it makes its final decision regarding the approval of sotagliflozin. While the FDA is not obligated to follow the committee's advice, it typically does so. A final decision is expected in the coming months.
Sotagliflozin is a dual SGLT1 (search) and SGLT2 (search) inhibitor. SGLT2 inhibitors are already used to treat type 2 diabetes and have shown kidney and cardiovascular benefits. Sotagliflozin's inhibition of SGLT1 in the gastrointestinal tract is thought to reduce glucose absorption, potentially offering additional benefits for blood sugar control. However, this mechanism may also contribute to the increased risk of DKA (search) observed in clinical trials.