Semaglutide prescription to be restricted to endocrinologists only: CDSCO panel tells Novo Nordisk
New Delhi: In a major development, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted marketing authorization to Novo Nordisk India for the anti-diabetic drug, Semaglutide 0.25 mg, 0.5 mg, 1 mg, 1.7 mg & 2.4 mg (Pre-filled pen) in line with the USFDA approved indication.
However, the expert panel has clarified that the prescription of the said drug should be restricted to endocrinologists only.
The approval came in the wake of a proposal moved by Novo Nordisk India Pvt. Ltd. for marketing authorization of the anti-diabetic drug, Semaglutide 0.25 mg, 0.5 mg, 1 mg, 1.7 mg & 2.4 mg (Pre-filled pen) with data generated on Indian patients before the committee.
Semaglutide is a glucagon-like peptide 1 receptor agonist which is used to improve glycemic control in type 2 diabetes mellitus. Semaglutide acts by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose.
Semaglutide was developed by Novo Nordisk. In December 2017, the United States approved an injection form of Semaglutide under the brand name Ozempic for medical usage. In 2019, an oral version of Novo Nordisk's diabetes drug semaglutide was approved by the US Food and Drug Administration (USFDA).
Furthermore, in June of 2021, the U.S. Food and Drug Administration approved semaglutide (Wegovy) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity.
The CDSCO panel, at its 78th SEC meeting for Endocrinology & Metabolism held on 24.08.2021 & 25.08.2021 at CDSCO, thoroughly examined the proposal presented by Novo Nordisk India Pvt. Ltd. for marketing authorization of Semaglutide, 0.25 mg, 0.5 mg, 1 mg, 1.7 mg & 2.4 mg (Pre-filled pen).
After detailed deliberation, the committee recommended the grant of marketing authorization of the drug in line with the USFDA's approved indication, subject to the following conditions:
1.Prescription of the drug should be restricted to endocrinologists only.
2.The duration of treatment should be up to 68 weeks based on available study data.
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