Submit safety data of initial 30 subjects : CDSCO Tells Novo-Nordisk On IcoSema and insulin icodec study
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New Delhi: Citing to remove the 'interim analysis' from the said condition, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has directed drug major Novo Nordisk regarding the antidiabetic fixed dose combination drug IcoSema and insulin icodec that the firm should submit the safety data of initial 30 subjects for review by committee and further continuation of the study in the country.
This came after the firm presented justification for the waiver of the condition no. (1) vide the permission dated 02-JUN-2022 for the COMBINE-1 trial protocol no. NN1535-4591, version 3.0 dated 10Aug2021,before the committee.
Insulin icodec is a long-acting basal insulin analogue, intended for once-weekly treatment, being developed by Novo Nordisk, for the treatment of type 1 and type 2 diabetes mellitus. The product has a terminal half-life of approximately 196 hours. Clinical development is underway in several countries.
After detailed deliberation, the committee recommended the removal of the 'interim analysis' from the said condition and further added that the firm should submit the safety data of initial 30 subjects for review by committee and further continuation of the study in the country.
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