11 to 3! FDA Advisory Committee Again Rejects Lexicon Pharmaceuticals' New Drug, Shattering Hopes for Type 1 Diabetes Patients!

The independent advisory committee of the U.S. Food and Drug Administration (FDA) voted on Thursday to deny a recommendation for Lexicon Pharmaceuticals' drug for additional treatment beyond insulin therapy to control blood glucose levels in adults with Type 1 diabetes and chronic kidney disease.

The committee's decision signifies a fresh setback in the company's long-standing efforts to gain a foothold in the market.

In the day's vote, the experts rejected the benefits of sotagliflozin over its potential risks by a margin of 11 to 3.

As early as the beginning of 2019, the FDA's advisory committee was divided on whether to recommend approval for a drug named sotagliflozin for the treatment of Type 1 diabetes. Soon after, the FDA did not approve the drug for market.

Lexicon Pharmaceuticals resubmitted the drug for market approval in June 2024.

The company is seeking approval for the drug for patients with Type 1 diabetes and chronic kidney disease whose kidney function scores or eGFR are in the ranges of 45 to less than 60, 60 to less than 90, and greater than 90.

However, some committee members suggested that the benefits of the drug might outweigh the risks for specific patient groups with a kidney function score of less than 60 to 90 or those with mild to moderate kidney disease.

But committee members expressed disappointment due to a lack of sufficient clinical data, stating that no prospective studies had been conducted on the patient subgroups that could potentially benefit the most.

"I voted against it, but I wished I could have voted for it. I didn't vote for it because the nature of the issue is very special, and the population involved is extremely special... If the issue involved people aged 60 to 90, my position might have been different," said Cecilia Wang, who voted against it, expressing skepticism about the data for people aged 60 to less than 90.

"The numbers are very limited. With the scarcity of relevant data, it's really hard for me to vote in favor of approving a new drug," she added.