Eli Lilly gets CDSCO Panel nod to modify prescription warning for Insulin Lispro Ultrarapid Injection

New Delhi: In line with the proposal for amending the warning statement of Insulin Lispro Ultrarapid Injection 100 IU & 200 IU, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Eli Lilly that the warning statement may be amended as "WARNING: To be sold by retail on the prescription of a Registered Endocrinologist and/or MD (Medicine).”

Furthermore, the expert panel added that the firm is required to submit Phase IV study data for expanding the prescription warning for registered medical practitioners.

This came after Eli Lilly and Company (India) presented the proposal for amendment in the warning statement for already approved drug products Insulin Lispro Ultrarapid (UR) 100 U/ml & 200 U/ml from "WARNING: To be sold by retail on the prescription of a Registered Endocrinologist only” to “Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.”

Insulin lispro is a modified form of fast-acting insulin used to control hyperglycemia in diabetes mellitus.

Insulin lispro is a rapid-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 diabetes. Insulin is prescribed for the management of diabetes mellitus to mimic the activity of endogenously produced human insulin, a peptide hormone produced by beta cells of the pancreas that promotes glucose metabolism. Insulin is released from the pancreas following a meal to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. Absorption of glucose into cells allows for its transformation into glycogen or fat for storage. Insulin also inhibits hepatic glucose production, enhances protein synthesis, and inhibits lipolysis and proteolysis, among many other functions.

Insulin lispro 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 the activation of downstream signaling 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. In humans, insulin is stored in the form of hexamers; however, only insulin monomers are able to interact with IR.

Ultra-Rapid Lispro (URLi) is a fast-acting insulin injection developed by Eli Lilly and Company to treat type 1 and type 2 diabetes. It contains treprostinil and citrate to accelerate insulin absorption at the injection site.

At the recent SEC meeting for endocrinology and metabolism held on November 13, 2024, the expert panel reviewed the proposal for amendment in the warning statement for already approved drug products Insulin Lispro Ultrarapid (UR) 100 U/ml and 200 U/ml from "WARNING: To be sold by retail on the prescription of a Registered Endocrinologist only” to “Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.”

After detailed deliberation, the committee recommended that warning statements may be amended as "WARNING: To be sold by retail on the prescription of Registered Endocrinologist and/or MD (Medicine).”

The committee further recommended the firm submit Phase IV study data for expanding the prescription warning for registered medical practitioners.

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