(Adds details from advisory committee meeting, background)
Jan 17 (Reuters) - Independent experts on an advisory panel to the U.S. Food and Drug Administration were divided over whether to recommend approval of a treatment for type 1 diabetes developed by Lexicon Pharmaceuticals Inc and France's Sanofi SA.
The panel on Thursday voted 8-8 when asked to assess the once-daily oral medicine, sotagliflozin, an add-on to insulin therapy for diabetic patients.
Insulin has been used to treat diabetes for decades, but can cause side effects such as hypoglycemia, a condition in which blood sugar falls to dangerously low levels, and weight gain.
Sotagliflozin, when taken along with insulin, could help
manage and maintain glucose levels while reducing the risk of hypoglycemia, Pablo Lapuerta, chief medical officer at Lexicon, told Reuters.
At the panel meeting, patients who were part of the trials advocated the drug's effectiveness, but FDA staff flagged the risk of a life-threatening side effect, leaving experts divided over whether the treatment's benefits outweighed the risks.
The FDA staff highlighted the risk of diabetic ketoacidosis, a condition in which acids called ketones build up when the body starts to use fat instead of glucose as a source of energy.
The trials tested the treatment in 200 mg and 400 mg doses.
The agency is expected to make a final decision by March 22.
(Reporting by Saumya Sibi Joseph and Tamara Mathias in Bengaluru; Editing by Sriraj Kalluvila)