Novartis gets CDSCO panel okay for phase 3 trial of Secukimunab
New Delhi: The pharmaceutical major, Novartis, has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of an immunomodulating agent and interleukin antagonist, Secukimunab.
This approval came after the drug-maker Novartis presented the protocol to conduct the Phase 3 clinical trial of Secukimunab before the committee.
Based on the country's unmet medical need, the committee observed that the trial medicine, Secukimunab could be an alternate therapy choice in people with active peripheral spondyloarthritis.
Spondyloarthritis is a category of disorders marked by inflammation of the spine and joints ("spondylitis" and "arthritis"). Spondyloarthritis comes in a variety of forms, including: Ankylosing spondylitis. Axial spondyloarthritis.
Secukinumab is a human IgG1κ monoclonal antibody that binds to the protein interleukin (IL)-17A and is marketed for the treatment of psoriasis, ankylosing spondylitis, and psoriatic arthritis. It inhibits a member of the cytokine family, interleukin 17A.
Secukinumab is a human monoclonal antibody designed for the treatment of uveitis, rheumatoid arthritis, ankylosing spondylitis, and psoriasis.
Secukinumab is an interleukin-17A (IL-17A) inhibitor marketed by Novartis. IL-17 is a group of proinflammatory cytokines released by cells of the immune system and exists in higher levels in many immune conditions associated with chronic inflammation. By targeting IL-17A, secukinumab has shown excellent efficacy in psoriasis by normalizing skin histology and was approved by the United States Food and Drug Administration on January 21, 2015 to treat adults with moderate-to-severe plaque psoriasis.
At recent SEC committee meeting for Analgesics and Rheumatology dated 10.02.2022, assessing the risk versus benefit to the patient, the expert panel noted that as the test drug is already approved in the country, the safety profile of the trial drug may justify the conduct of the proposed trial.
In addition to this, while deliberating on the innovations vs. existing therapeutic options, the committee found that the primary objective of the study is to demonstrate the superiority of Secukinumab compared to placebo based on Modified Peripheral SpondyloArthritis Response Criteria 40 (mPSpARC40) response at week 16 in participants with active pSpA.
Furthermore, analysing the unmet medical need in the country, the committee noted that the trial drug may be an alternative treatment option in subjects with active peripheral spondyloarthritis.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial as per the protocol presented.
