Insulin degludec may be considered during pregnancy: CDSCO Panel tells Novo Nordisk

This came after the firm presented the proposal for the update in the prescribing information of the antidiabetic drug Insulin degludec.

Insulin degludec is a long-acting, man-made version of human insulin. Insulin degludec works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.

Insulin detemir binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units.The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor.The bound receptor autophosphorylates and phosphorylates numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc, and Gab 1. Activation of these proteins leads to activation of downstream signalling molecules including PI3 kinase and Akt.Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC), both of which play critical roles in metabolism and catabolism.

At the recent SEC meeting for Endocrinology & Metabolism held on January 19th & 20th 2022, the expert panel reviewed the proposal for the update in the prescribing information of the antidiabetic drug Insulin degludec solution 100U/ml and 200U/ml.

After detailed deliberation, the committee recommended to include the following in the prescribing information of the drug in the section of use in special populations: “The treatment with Insulin degludec may be considered during pregnancy, if clinically needed”.