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.
Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) are both types of axial spondyloarthritis (axSpA), an inflammatory arthritis that affects the spine and joints
Ixekizumab is a biologic medication used to treat psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis. Biologic medications are proteins designed by humans that affect the immune system.
Ixekizumab is a humanized monoclonal antibody (IgG) that selectively binds to interleukin 17A (IL-17A); this prevents interleukin 17A from binding to the IL-17 receptor. Thus, this attenuates an inflammatory response mediated by interleukin 17A.
At the recent SEC meeting for analgesics and rheumatology held on October 3, 2024, the expert panel reviewed 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 prefilled syringe (r-DNA origin) with the request for a local clinical trial waiver.
After detailed deliberation, the committee noted that there is no efficacy data in Indian subjects.
In continuation, the expert panel opined the firm to submit efficacy data of the Indian population for the approval of proposed indications.
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