Sanofi plea for Insulin Glargine, Lixisenatide antidiabetic combination rejected by CDSCO panel

Insulin glargine is produced by recombinant DNA technology utilising Escherichia coli (K12 strain) as the production organism.

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis. 

Lixisenatide is a recombinant DNA produced polypeptide analogue of human glucagon-like peptide-1 (GLP-1) which is used in combination with diet and exercise in the therapy of type 2 diabetes, either alone or in combination with other antidiabetic agents. It is sold under the brand name Adlyxin by Sanofi-Aventis. Adlyxin received FDA approval on July 28, 2016.

At the latest SEC meeting for Endocrinology & Metabolism held on 24.08.2021 & 25.08.2021 at CDSCO, the committee thoroughly reviewed the drug-maker Sanofi India's proposal for marketing authorization of Fixed Ratio combination of Insulin Glargine and Lixisenatide (100 U +50 µg/33µg).

After extensive evaluation, the committee noted that the primary endpoint was not achieved in the India-specific trial with the Fixed Ratio combination. Accordingly, after detailed deliberation, the committee didn't recommend the grant of marketing authorization.