Biocon Told to Submit Detailed Toxicity, SAE Data on Semaglutide Prefilled Pen After Animal Deaths
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has opined that Biocon Pharma furnish additional data regarding the subacute toxicity and serious adverse event (SAE) reports related to its proposed Semaglutide Solution for Injection in prefilled pens (2 mg/1.5 mL, 4 mg/3 mL, and 8 mg/3 mL, 6.8 mg/3 mL, 9.6 mg/3 mL; synthetic origin).
This came after Biocon Pharma presented the data/information on survived and dead animals along with a causality assessment of animals that died during the subacute toxicity study and data/information on serious adverse events (SAE) reported in the BE study.
The expert panel directed the firm to present the daily monitoring data for physiological parameters, particularly animals with mortality. Also, the firm should submit the report by the veterinary pathologist stating the cause of mortality in the animals.
Furthermore, it suggested that the firm should present the causality assessment and clear history on the number of studies in which the SAE reported subject had participated at the site and health status. In addition to this, the committee stated that the firm should submit the complete CRF as well as the admission and discharge summary of the SAE reported in the subject.
Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.
GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas.
Semaglutide is 94% similar to human GLP-1. Analogs of this hormone, such as semaglutide, stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion.
They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.
At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the data/information on survived and dead animals along with a causality assessment of animals that died during the subacute toxicity study and data/information on serious adverse events (SAE) reported in the BE study of Semaglutide Solution for Injection in prefilled pens.
After detailed deliberation Committee opined that:
1) The firm should present the daily monitoring data for physiological parameters, particularly for animals with mortality. Also, the firm should submit the report by the veterinary pathologist stating the cause of mortality in the animals.
2) The firm should present the causality assessment and clear history on the number of studies in which the SAE reported subject had participated at the site and health status.
3) The Firm should submit the complete CRF as well as the admission and discharge summary of the SAE reported in the subject.
Accordingly, the expert panel suggested that the firm should submit the above-mentioned data/information to CDSCO for further review by Committee.
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