CDSCO Panel Asks Novartis to Submit Revised Protocol, Dose Changes for Ianalumab Phase III Trial

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-06-01 10:30 GMT | Update On 2025-06-01 10:30 GMT

New Delhi: Reviewing the Phase III clinical of the Ianalumab (VAY736) presented by Novartis, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) opined that the firm should submit revised protocol and dose modification of the proposed drug for further review.

This came after the firm presented phase III clinical study protocol no.: CVAY736L12301 version no. 00 dated 04-FEB-2025.

Ianalumab (VAY736) is an anti-B-cell activating factor (BAFF) receptor fully human monoclonal antibody, engineered for direct ADCC-mediated B-cell depletion.

Ianalumab (previously known as VAY736) is a novel BAFF-targeting antibody, which was recently evaluated in patients with pSS [80]. 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 meeting for Renal held 20th May 2025, the expert panel reviewed the phase III clinical study protocol no.: CVAY736L12301 version no. 00 dated 04-FEB-2025.

After detailed deliberation, the committee opined that the firm shall submit revised protocol and dose modification for further review by the committee.

Also Read: Dr Reddy's Gets SEC Nod for Higher Semaglutide Dose in Ongoing Phase III Study, Govt Sites Mandated

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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.

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CDSCO Panel Asks Novartis to Submit Revised Protocol, Dose Changes for Ianalumab Phase III Trial

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