CDSCO Panel Approves Novartis Protocol Amendment Proposal To Study Ianalumab

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-06-28 12:00 GMT | Update On 2024-06-28 12:00 GMT

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.

Also Read: Expansion of warning statement may be considered after submission of first year PSUR data: CDSCO panel on AstraZeneca's anticancer drug

Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd

Dr. Divya Colin

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.

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

CDSCO Panel Approves Novartis Protocol Amendment Proposal To Study Ianalumab

Similar News