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CDSCO Panel Approves Novartis Protocol Amendment Proposal To Study Ianalumab
![CDSCO Panel Approves Novartis Protocol Amendment Proposal To Study Ianalumab CDSCO Panel Approves Novartis Protocol Amendment Proposal To Study Ianalumab](https://medicaldialogues.in/h-upload/2024/02/17/750x450_232451-novartis-50.webp)
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis' protocol amendment proposal for the clinical trial protocol titled, "A randomized, double-blind, parallel group, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy, safety, and tolerability of ianalumab on top of standard-of-care therapy in participants with active lupus nephritis (SIRIUS-LN)."
This drug is being developed by Novartis. It is a novel BAFF-targeting antibody that was recently evaluated in patients with pSS. Ianalumab prevents BAFF signaling through its receptor BAFF-R and, in addition, depletes BAFF-R-expressing B-cells through antibody-dependent cellular cytotoxicity.
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Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751