Drugs not yet marketed in India, Submit PSUR Data: CDSCO Panel Tells Novo Nordisk on Semaglutide injection
New Delhi: Noting that proposed drug products Semaglutide Injection 0.25mg/0.5mg/1mg/1.7mg/2.4mg (Wegovy) and Semaglutide Injection 0.25mg/0.5mg/1mg/1.7mg/2.4mg (Wegovy FlexTouch) are not yet marketed in India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Novo Nordisk to submit periodic safety update reports (PSUR) to establish the safety in the Indian population for further review by the committee in the presence of pediatrician.
This came after Novo Nordisk presented the proposal for a grant of permission for the additional indication of the drug products Semaglutide Injection 0.25mg/0.5mg/1mg/1.7mg/2.4mg (Wegovy)and Semaglutide Injection 0.25mg/0.5mg/1mg/1.7mg/2.4mg (Wegovy Flextouch), i.e., indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents aged 12 years and above with obesity and body weight above 60 kg.
The committee mentioned that the medicine is not currently available for purchase in India.
The medication available in India is Novo Nordisk's Rybelsus pill, which is a pill that has the same components as Wegovy. Recently, the FDA authorized Wegovy, a once-weekly injectable prescription medication, to help adults who are obese or who weigh too much, in addition to having medical issues related to their weight, lose weight. Wegovy is a brand name for semaglutide.
Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.
GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas. Semaglutide is 94% similar to human GLP-1. Analogs of this hormone, such as semaglutide, stimulate the synthesis of insulin3 by stimulating pancreatic islet cells and reducing glucagon secretion.3 They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.
At the recent SEC meeting for Endocrinology and Metabolism held on July 24, 2024, the expert panel reviewed the proposal for grant of permission for the proposed additional indication of the drug product, Semaglutide Injection.
The committee noted that the drug product is not yet marketed in India.
After detailed deliberation, the committee recommended the firm submit PSUR data to establish safety in the Indian population for further review of the present proposal by the committee in the presence of a pediatrician.
