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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-31T18:00:42+05:30 | Updated On 31 July 2024 6:00 PM IST

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.

Also Read: Cipla Gets CDSCO Panel Nod to Study Plazomicin Injection

somapacitanNovoNordiskcdscoprotocol amendmenthuman growth hormone

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751