Alkem Secures CDSCO Panel Approval for Synthetic Semaglutide in Obesity Management
New Delhi: Drug major Alkem Laboratories Limited has received a key regulatory clearance from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) for the manufacture and marketing of Semaglutide Injection (synthetic origin) for chronic weight management, following the acceptance of its Phase III clinical trial (CT) report.
The approval covers multiple strengths of Semaglutide Injection, including 0.25 mg {(1mg /1.5ml) (0.68 mg/ml)}, 0.5 mg {(2 mg/1.5ml) (1.34 mg/ml)}, 1mg {(4 mg/3ml) (1.34 mg/ml)}, 1.7 mg {(6.8 mg/3 ml) (2.27 mg/ml)} & 2.4 mg {(9.6 mg/3 ml) (3.2 mg/ml) (Synthetic origin).
The Committee specified that the drug is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater (obesity), or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition, such as hypertension, type 2 diabetes mellitus, or dyslipidemia.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for weight management and metabolic control. GLP-1 is a physiological hormone that helps regulate blood glucose levels by stimulating insulin secretion, reducing glucagon release, and slowing gastric emptying. Semaglutide, which is structurally similar to human GLP-1, binds selectively to GLP-1 receptors and exerts glucose-dependent effects that support weight reduction and metabolic balance.
At the recent SEC meeting, Alkem Laboratories Limited presented the Phase III CT report for Semaglutide Injection for chronic weight management. After detailed deliberation, the committee accepted the Phase III CT report and recommended the grant of permission for manufacture and marketing of Semaglutide Injection across the approved strengths.
However, the recommendation has been made subject to the condition that the firm must conduct a Post-Marketing Surveillance (PMS) study.
Indication
It is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of
• 30 kg/m2 or greater (obesity) or
• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
Accordingly, the expert panel directed that Alkem Laboratories Limited should submit the PMS study protocol to CDSCO within three months from the date of approval of the drug product for review by the committee.
