Novo Nordisk Gets CDSCO Panel conditional nod to study Insulin icodec
New Delhi: The drug major Novo Nordisk has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III b clinical study of the Insulin icodec, an investigational ultralong-acting basal insulin analogue.
However, this approval is subject to the condition that the firm should submit the addendum, clearly defining rescue and withdrawal criteria.
This came after the drug maker Novo Nordisk presented Phase 3b clinical study protocol no. NN1436-7724.
Insulin icodec is an ultra-long-acting basal insulin analogue developed by Novo Nordisk. It is currently undergoing Phase 3 trials.
It is given as a weekly subcutaneous injection to help control blood sugar levels in people with diabetes. With a duration of action of over 8 days (compared to 42 hours for insulin degludec, the previous longest-acting insulin analogue), it becomes a once-weekly basal insulin. This substance is composed of two peptide chains, disulfide bridges. In addition, the 21 amino acid residue chain has two internal disulfide bridges and the second chain is 29 residues long.
At the recent SEC meeting for endocrinology and metabolism held on 11 Jan 2023, the expert panel reviewed the phase 3b clinical study protocol of Insulin icodec.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm with the condition that the addendum, clearly defining rescue and withdrawal criteria shall be submitted to CDSCO.
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