Novo Nordisk Gets CDSCO Panel Nod to Conduct India-Specific PMS Studies on Somapacitan
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Novo Nordisk India to conduct India-specific post-marketing surveillance (PMS) studies for its approved drug product Somapacitan Injection.
The approval covers Somapacitan Injection 5 mg/1.5 ml, 10 mg/1.5 ml and 15 mg/1.5 ml solution for injection in pre-filled pen (PFP), indicated for the treatment of growth hormone deficiency.
During the meeting, the firm presented its proposal to conduct following India-specific PMS studies for the approved drug product Somapacitan Injection 5 mg/1.5 ml, 10 mg/1.5 ml and 15 mg/1.5 ml solution for injection in PFP -
i. A multicenter, prospective, single-arm, observational, non-interventional, postmarketing surveillance study to investigate safety of somapacitan in adults with growth hormone deficiency (AGHD) under routine clinical practice in India vide Protocol No. NN8640-8387, Version 1.0 dated 29 Jul 2025.
ii. A Non-Interventional, Observational Study to Investigate Long-Term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients with Growth Hormone Deficiency During Routine Clinical Practice in India vide Protocol No. NN8640-8388, Version 1.0 dated 29 Jul 2025.
Somapacitan is a human growth hormone analog 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). IGF-1 causes growth in bones and muscle tissue. Growth hormones more directly cause the fusion of myoblasts and myotubes to cause muscle fiber growth, activate neural stem cells, and induce chondrocyte proliferation.
Somapacitan is indicated as a replacement for growth hormone in adult patients with growth hormone deficiency.
At the recent SEC meeting, the expert panel reviewed the proposal presented by Novo Nordisk India to conduct India-specific PMS studies for the approved drug product Somapacitan Injection 5 mg/1.5 ml, 10 mg/1.5 ml and 15 mg/1.5 ml solution for injection in PFP.
After detailed deliberation, the committee recommended the approval to conduct the proposed PMS studies as per protocols presented by the firm.
