Pfizer gets CDSCO Panel nod to study Somatrogon
Pfizer
New Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the active post-marketing surveillance study of Somatrogon 24mg/1.2ml and 60mg/1.2 ml.
This came after Pfizer presented the revised protocol to conduct the active surveillance study titled “A multicenter, non interventional prospective active surveillance study among participants receiving Somatrogon under routine clinical care in India” vide protocol number C0311026, version:V 2.0 dated 29.05.2024.
Somatrogon is a long-acting recombinant human growth hormone used in the long-term treatment of pediatric patients who have growth failure due to growth hormone deficiency.
Somatrogon mimics the physiological actions of endogenous growth hormones, such as cell proliferation, metabolism, and growth. It was also shown to increase the serum concentration of insulin-like growth factor (IGF-1).
Growth hormone is a key hormone that promotes body growth and regulates carbohydrate, protein, and lipid metabolism. Somatrogon is a hormone replacement therapy that aims to restore deficient levels of growth hormone (GH). Like endogenous growth hormone, somatrogon binds to the GH receptor, which leads to the binding of JAK2 to the GH receptor and activation of JAK2. Activation of JAK2 and phosphorylation of both JAK2 and GHR initiate the recruitment of various signaling proteins and facilitate multiple signaling pathways responsible for growth and metabolism. One of the activated signaling pathways is the STAT5b signaling pathway, which is critical for the effect of GH on body height.
At the recent SEC meeting for endocrinology and metabolism held on July 24, 2024, the expert panel reviewed the revised protocol to conduct the active surveillance study titled “A multicenter, non-interventional prospective active surveillance study among participants receiving Somatrogon under routine clinical care in India” via protocol number C0311026, version: V 2.0 dated 29.05.2024.
After detailed deliberation, the committee recommended the firm for conducting the active post-marketing surveillance study as per the revised protocol presented by the firm.
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