7. Drug and device update

Sanofi submits new diabetes drug application to USFDA

Sanofi has submitted an application to the U.S. Food and Drug Administration (FDA) for a single daily injection, Lixilan to treat adults with type 2 diabetes. Sanofi said it had requested a six-month review of its new drug application by the FDA, rather than the standard 10 months.

Lilly Discontinues Development Insulin Peglispro

Lilly has discontinued the development of its new basal insulin, Peglispro. in part due to liver safety issues with the drug that emerged in the phase 3 results.

Its “liver-selective” mechanism which works primarily in the liver to take up glucose, and more closely mimics the way natural insulin works in the body in people without diabetes had given hopes to diabetes patients. In clinical trials, peglispro also lead to superior A1c reductions, nighttime hypoglycemia reductions, and weight loss advantages over Lantus. Despite these benefits, the safety issues would have likely made FDA approval a long shot which made Lilly discontinue its development.

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