Novo Nordisk Gets CDSCO Panel Nod To Import, Market Insulin Icodec to treat diabetes mellitus in adults
New Delhi: The drug major Novo Nordisk has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import and market the Insulin Icodec 700 U/ml, 1050 U/1.5 ml, and 2100 U/3 ml for the indication of treatment of diabetes mellitus in adults.
However, this approval is subject to the condition that the drug major, Novo Nordisk, conduct an active post-market surveillance (PMS) study.
Furthermore, the expert panel stated that the drug shall be prescribed only by a registered endocrinologist or physician with a postgraduate qualification in medicine.
This came after the firm presented the product approval from the NRA of the country of origin, i.e., the EMA for grant of permission to import and market Insulin Icodec 700 U/ml, 1050 U/1.5 ml, and 2100 U/3 ml.
Insulin icodec is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. It is currently under investigation for the treatment of type 1 and 2 diabetes in the phase 3 ONWARDS programme.
Insulin remains the cornerstone of diabetes treatment. However, initiation of insulin therapy in type 2 diabetes is often delayed, despite uncontrolled blood sugar levels, leading to an increased risk of diabetes-related complications.
The insulin icodec molecule has been engineered by modifying human insulin to give it a prolonged half-life of approximately 7 days. Three amino acid substitutions have been introduced to provide molecular stability, minimise the enzymatic breakdown of insulin icodec, and reduce receptor-mediated clearance.
Insulin icodec is formulated at 700 units/mL to ensure that the injection volume is similar to that of once-daily basal insulin. It is designed to be injected subcutaneously once a week with an easy-to-use pen and optional digital support for personalized automated dose guidance.
At the recent SEC meeting for endocrinology and metabolism held on June 19, 2024, the expert panel reviewed the product approval from NRA of country of origin, i.e. EMA for grant of permission to import and market Insulin Icodec 700 U/ml, 1050 U/1.5 ml, 2100 U/3ml.
After detailed deliberation, the committee recommended the grant of permission to import and market Insulin Icodec 700 U/ml, 1050 U/1.5 ml, and 2100 U/3 ml for the indication of treatment of diabetes mellitus in adults with the following conditions:
Accordingly, the expert panel suggested that the firm submit an active PMS study protocol within three months of the grant of marketing authorization permission and a revised PI of the product to CDSCO for approval.
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