CDSCO Panel Approves Eli Lilly's Protocol Amendment Proposal for Mirikizumab study

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-12-30 12:30 GMT | Update On 2024-12-30 12:30 GMT

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.

Also Read: Sun Pharma Laboratories Gets CDSCO Panel Nod for Etifoxine Hydrochloride Capsules study

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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CDSCO Panel Approves Eli Lilly's Protocol Amendment Proposal for Mirikizumab study

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