Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults
New Delhi: Pharmaceutical major Eli Lilly has got marketing authorization from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for Mirkizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in Prefilled Syringe (PFS) indicated for the treatment of moderate to severe active ulcerative colitis in adult.
This came after the drug maker Eli Lilly presented the proposal to import and market Mirikizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS indicated for the treatment of moderate to severe active ulcerative colitis in adults based on the results of global clinical trials conducted by the firm including the Indian population.
The committee noted that the drug is approved in USA, Europe, Canada, Japan, Australia and other countries.
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.
Mirikizumab is an anti-IL-23 monoclonal antibody used as a second-line therapy for moderate-to-severe active ulcerative colitis.
Mirikizumab-mrkz injection is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults.
At the recent SEC meeting for Gastroenterology and Hepatology held on 13th March 2024, the expert panel reviewed the proposal presented by Eli Lilly to import and market Mirikizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS indicated for the treatment of moderate to severe active ulcerative colitis in adults based on the results of global clinical trials conducted by the firm including the Indian population.
After detailed deliberation, the committee recommended a grant of marketing authorization to the firm for Mirkizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS subject to the condition that the firm should conduct Phase IV clinical trial in the country.
Accordingly, the expert panel suggested that the firm should submit a Phase IV clinical trial protocol to CDSCO within 3 months of marketing approval.
