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