0149 GMT October 18, 2019
The panel voted 8-8 when asked to assess the once-daily oral medicine, sotagliflozin, an add-on to insulin therapy, Reuters reported.
Insulin has been used to treat diabetes for decades, but side effects include hypoglycemia, a condition in which blood sugar falls to dangerously low levels, and weight gain.
Sotagliflozin, which was tested in two doses, could help manage and maintain glucose levels while reducing the risk of hypoglycemia, Pablo Lapuerta, chief medical officer at Lexicon, told Reuters.
At the meeting, patients who were part of the trials advocated the drug’s effectiveness, but FDA staff flagged the risk of diabetic ketoacidosis (DKA), leaving experts divided over whether the treatment’s benefits outweighed the risks.
DKA is a life-threatening condition in which acids called ketones build up when the body starts to use fat instead of glucose as a source of energy.
“I was not convinced it was a reasonable trade-off,” said panel member Martha Nason, who voted against the approval.
Patients treated with the drug said it reduced blood sugar fluctuations and helped them lose weight.
The companies proposed a risk evaluation and mitigation strategy (REMS) that involved educating patients and physicians and said patients should be required to regularly test their ketone levels.
Not all of the estimated 1.3 million American adults with type 1 diabetes will be eligible to receive sotagliflozin, the companies told Reuters.
“It is for those patients who are truly committed in their self care and willing to follow the basic steps of monitoring,” said Rachele Berria, head of Sanofi’s US diabetes medical unit.
The drug is also not intended for newly diagnosed patients, predominantly children and young adults, for whom the priority is to recognize their optimal level of insulin, added Lapuerta.
“The task going forward will be to have a REMS strategy that will effectively select and maintain the patients and providers who can use this drug in the safest way possible,” said Rebecca Brown, a panel member who voted for the approval.
The agency is expected to make a final decision by March 22.