Submit efficacy data of Indian population: CDSCO Panel Tells Eli Lilly for approval of additional indications of Ixekizumab
New Delhi: Citing that there is no efficacy data in the Indian population, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Eli Lilly to submit the efficacy data of the Indian population for the approval of Ixekizumab solution for injection, 80 mg/ml, in the prefilled auto-injector and prefilled syringe (rDNA origin) for additional indications, i.e., ankylosing spondylitis and nonradiographic axial spondyloarthritis.
This came after Eli Lilly and Company presented the proposal for the approval of additional indications, i.e., ankylosing spondylitis and non-radiographic axial spondyloarthritis, of Ixekizumab solution for injection, 80 mg/ml in a prefilled auto-injector and a prefilled syringe (r-DNA origin) with a request for local clinical trial waiver.
The firm has presented the safety and efficacy results of global clinical trials (COAST V, W, X, and Y) conducted in the proposed indication.
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