Novo-Nordisk gets CDSCO Panel nod to study Human Growth Hormone Analogue Somapacitan
New Delhi: In line with the pharmaceutical major Novo-Nordisk's proposed protocol amendment on the study of human growth hormone Somapacitan, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission for the conduct of the trial as per the proposed amended protocol.
This came after the firm presented the proposed protocol amendment version 8.0 dated 08MAR2022 under the REAL 5 protocol no. NN8640-4245, before the committee.
Somapacitan is a human growth hormone analogue for subcutaneous injection and is indicated for adults with growth hormone deficiency.
Growth hormone deficiency is a disorder characterized by inadequate growth hormone production from the anterior pituitary gland, a small gland located at the base of the brain that produces several hormones. Adult patients with growth hormone deficiency can receive growth hormone as a replacement therapy.
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 fibre growth, activate neural stem cells, and induce chondrocyte proliferation.
Earlier, the Medical Dialogues Team had reported that the Food and Drug Administration (FDA) had approved Sogroya (somapacitan-beco; Novo Nordisk) injection for the replacement of endogenous growth hormone in adults with growth hormone deficiency.
At the recent SEC meeting for Endocrinology and Metabolism held on September 9th, 2022, the expert panel reviewed the proposed protocol amendment version 8.0 dated 08MAR2022 under the REAL 5 protocol no. NN8640-4245, presented by pharmaceutical major Novo-Nordisk.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial of the human growth hormone Somapacitan as per the proposed amended protocol.
