CDSCO Panel Approves Novartis Protocol Amendment Proposal To Study Ianalumab

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-28T17:30:07+05:30 | Updated On 28 Jun 2024 5:30 PM IST

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 came after the firm presented protocol amendment version 03 dated 14.12.2023 protocol No. CVAY736K12301.

Ianalumab development code VAY736 is a monoclonal antibody that is being investigated for autoimmune hepatitis, multiple sclerosis, pemphigus vulgaris, rheumatoid arthritis, Sjögren syndrome, and systemic lupus erythematosus.

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.

At the recent SEC for renal held on June 6, 2024, the expert panel reviewed the proposal for protocol amendment version 03 dated 14.12.2023 protocol No. CVAY736K12301.

After detailed deliberation, the committee recommended the approval of protocol amendment as presented by the firm.

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novartisianalumablupas nephritisprotocol amendment

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

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: drkohli@medicaldialogues.in. Contact no. 011-43720751