FDA rejects Sanofi-Lexicon add-on pill for type 1 diabetes


The logo of Sanofi is pictured during the Viva Tech start-up and technology summit in Paris, France, May 25, 2018. REUTERS/Charles Platiau

(Reuters) – 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.

Reporting by Manojna Maddipatla and Tamara Mathias in Bengaluru; editing by Bill Berkrot

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