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.
Also Read: Dr Reddy's Gets SEC Nod for Higher Semaglutide Dose in Ongoing Phase III Study, Govt Sites Mandated
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.