CDSCO Panel Approves Novo Nordisk’s Protocol Amendment proposal to study Somapacitan

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major Novo Nordisk’s protocol amendment proposal for the study of the human growth hormone analog Somapacitan.

This came after Novo Nordisk presented protocol amendment version 12.0 dated 21 March 2024 protocol no. NN8640-4245. This is a dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older.

Somapacitan is a human growth hormone analog subcutaneous injection indicated for adults with growth hormone deficiency.Somapacitan binds to the growth hormone receptor and induces intracellular signalling to up-regulate insulin-like growth factor I (IGF-1).1,6 IGF-1 causes growth in bones and muscle tissue. Growth hormones more directly cause the fusion of myoblasts and myotubes to cause muscle fibre growth, activate neural stem cells, and induce chondrocyte proliferation.

At the recent SEC meeting for endocrinology and metabolism held on July 11, 2024, the expert panel reviewed the protocol amendment version 12.0 dated 21 March 2024 protocol no. NN8640-4245.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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