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

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-07-31 12:30 GMT | Update On 2024-07-31 12:30 GMT

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

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Dr. Divya Colin

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.

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

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

Similar News

AstraZeneca Faces NPPA Heat Over Symbicort Pricing, Slapped Rs 60 Crore Showcause Notice

Fixed Dose Combination of Metformin-Voglibose Now CDSCO Approved

Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus' Phase III CT Waiver Request for Voclosporin

Torrent Pharma Brand Misused in Online Investment Scam, Fake Portals Promising High Returns Busted

Alembic Pharma gets USFDA EIR for 2 API facilities in Panelav

Raid at quack clinic in Telangana, drugs illegally stocked for sale seized

Dr Reddys Labs gets 5 observations from USFDA for Bachupally facility

USFDA concludes audit at Cohance Lifesciences Jaggaiahpet facility