Setback: USFDA rejects Sanofi, Lexicon Sotagliflozin for type 1 diabetes

The decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin, should be approved as an add-on to insulin therapy.

New Delhi: The U.S. Food and Drug Administration declined to approve a drug developed by Sanofi SA and Lexicon Pharmaceuticals Inc intended for use with insulin in patients with type 1 diabetes, the companies said on Friday.

The decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin, should be approved as an add-on to insulin therapy.

The setback comes as Sanofi works to revive declining sales from its diabetes division, and as the French drugmaker faces increasing pressure from politicians and patient advocacy groups over the rising cost of its insulin products.

Sotagliflozin, works by inhibiting the proteins SGLT1 and SGLT2 to help regulate blood glucose levels and reduce the risk of weight gain.

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Wedbush analyst Liana Moussatos had forecast annual U.S. sotagliflozin sales exceeding $450 million for type 1 diabetes by 2024.

The FDA panel members in January had raised concerns of the risk of diabetic ketoacidosis (DKA), leaving them 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.

The companies had proposed risk evaluation and mitigation strategy (REMS) for the drug and have said regular testing of ketone levels should be required.

Other SGLT2 inhibitors, AstraZeneca's Farxiga, Johnson & Johnson's Invokana and Eli Lilly and Co and Boehringer Ingelheim's Jardiance, are approved for type 2 diabetes. They work by removing excess blood sugar through the urine and also cause some weight loss.

Type 1 diabetes affects about 1.3 million Americans, according to the American Diabetes Association.

Sanofi and Lexicon said they will work with the FDA to determine the appropriate next steps.