CDSCO Panel Approves Eli Lilly's Protocol Amendment Proposal for Mirikizumab study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Eli Lilly's protocol amendment proposal for Mirikizumab study.
This came after the firm presented protocol amendment (e) dated 10 September 2024 protocol no. I6T-MC-AMAX. This is a phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in patients with crohn's disease.
Mirikizumab is a monoclonal antibody developed by Eli Lilly intended to treat ulcerative colitis. It inhibits the actions of interleukin-23 (IL-23), a pro-inflammatory cytokine that activates pathways contributing to the development of inflammatory diseases
Mirikizumab is a monoclonal antibody directed against the p19 subunit of human interleukin-23 (IL-23). The binding of mirikizumab to its target inhibits the interaction between IL-23 and the IL-23 receptor, thereby normalizing the overproduction of effector cytokines driving the pathogenesis of inflammatory diseases, including ulcerative colitis.
At the recent SEC meeting for gastroenterology and hematology held on 12th December 2024, the expert panel reviewed the protocol amendment (e) dated 10 September 2024 protocol no. I6T-MC-AMAX.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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