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 The panel on Thursday voted 8-8 when asked to assess the once-daily
oral medicine, sotagliflozin, an add-on to insulin therapy.
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.
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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 U.S. 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.
(Reporting by Saumya Sibi Joseph and Tamara Mathias in Bengaluru;
Editing by Sriraj Kalluvila)
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