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.
Following its first global approval in Japan in December 2014, secukinumab was approved by the European Commission on January 15, 2015, and by the FDA a few days after (January 21, 2015). It is currently approved to treat a number of chronic inflammatory conditions, such as plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
At the recent SEC meeting for dermatology and allergy held on 12 October 2023, the expert panel reviewed the proposal for an update in the package insert of Secukinumab 75mg/150mg/300mg for change in posology and pharmacodynamic properties.
After detailed deliberation, after detailed deliberation, the committee recommended approval of the updated package insert dated 12.04.2022.
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