Conduct Active Post Marketing Surveillance Study: CDSCO Panel tells Novo Nordisk on Somapacitan Injection

New Delhi: Granting approval for waiving off the Phase-IV study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Novo Nordisk to conduct the Active Post Marketing Surveillance (PMS) study of Somapacitan Injection 5 mg/1.5 ml, 10mg/1.5ml and 15 mg/1.5 ml solution for injection in PFP.

This came after Novo Nordisk presented the proposal for waiver of the Phase-IV clinical study imposed in the marketing authorization permission granted for the drug Somapacitan.

Somapacitan is a long-acting recombinant human growth hormone derivative. Somatropin injection is used to replace growth hormone (a natural hormone produced by your body) in adults and children with growth hormone deficiency. Somatropin injection is also used to increase growth in children with certain conditions that affect normal growth and development.

Somapacitan binds to the growth hormone receptor and induces intracellular signaling to up-regulate insulin-like growth factor I (IGF-1). IGF-1 causes growth in bones and muscle tissue.

At the recent SEC meeting for endocrinology and metabolism held on 10th April 2024, the expert panel reviewed the proposal for waiver of the Phase-IV clinical study imposed in the marketing authorization permission granted for the drug Somapacitan.

After detailed deliberation, the committee agreed to a waiver of the Phase-IV study condition and recommended conducting an Active Post-Marketing Surveillance (PMS) study.

Accordingly, the expert panel suggested that the firm should submit the protocol to conduct an Active PMS study within three months.

Also Read: Eli Lilly Gets CDSCO Panel Nod to Study Lepodisiran

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