FDA Advisers Vote Against Lexicon Pharma’s Add-on Drug for Type 1 Diabetes

(Reuters) -Independent advisers to the U.S. Food and Drug Administration on Thursday voted against recommending Lexicon Pharmaceuticals’ add-on treatment to insulin therapy for managing blood glucose levels in adults with type 1 diabetes and chronic kidney disease.

The decision by the independent experts marks another setback for the company’s years-long effort to market the drug.

The panel on Thursday voted 11-3 against the benefits of the drug, sotagliflozin, outweighing its risks.

In early 2019, the FDA’s advisory panel were divided over whether to recommend approval of the drug chemically known as sotagliflozin for type 1 diabetes. Shortly later, the FDA declined to approve the drug.

Lexicon resubmitted the marketing application for the drug in June 2024.

The company was seeking approval for the drug in patients with type 1 diabetes and chronic kidney disease who had a kidney function score or eGFR of 45 to less than 60, 60 to less than 90 and greater than 90.

However, some panel members felt the benefits of the drug outweighed its risks in a specific subpopulation of patients who had a kidney function score of 60 to less than 90 or those who have mild to moderate kidney disease.

But the panel members said they were “disappointed” due to the lack of clinical data as the subgroup of patients who might benefit the most were not prospectively studied.

“I voted no, but I wanted to vote yes. I didn’t vote yes because of the very specific nature of the question and the very specific population … I would have felt differently if the question were about the 60 to 90 category,” said voting member Elizabeth Chrischilles.

Cecilia Wang, who voted no, said she was not convinced by the data for the 60 to less than 90 subgroup.

“The numbers were incredibly small. I have a really hard time voting to approve a drug when there’s little relevant data,” Wang said.

(Reporting by Sneha S K and Sruthi Narasimha Chari in Bengaluru; Editing by Shailesh Kuber and Maju Samuel)