CDSCO Panel approves Novartis proposal to update package insert of Secukinumab
New Delhi: The Subject Expert Committee (SEC) functional under the Center Drug Standard Control Organisation (CDSCO) has granted approval to drug major Novartis to update the package insert of Secukinumab 75mg/150mg/300mg for change in posology and pharmacodynamic properties.
This came after the expert panel noted that the changes proposed in the package insert are in line with the approval of EU SmPC (A Summary of Product Characteristics).
Secukinumab is an immunomodulating agent and interleukin antagonist used to manage plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, along with other joint inflammatory disorders.
Secukinumab is a fully human monoclonal IgG1/κ antibody against interleukin-17A (IL-17A), a proinflammatory cytokine implicated in various chronic immune-mediated inflammatory disorders, such as plaque psoriasis. By blocking the actions of IL-17A, secukinumab works to inhibit the pro-inflammatory pathways that drive immune-mediated inflammatory disorders.
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