CDSCO Panel Recommends Protocol Amendment for Novartis’ Ianalumab Trial
New Delhi: The Subject Expert Committee (SEC) on Haematology, functional under the Central Drugs Standard Control Organisation (CDSCO) has recommended for approval of a protocol amendment in an ongoing global clinical trial of Ianalumab (VAY736) by Novartis Healthcare Private Limited.
The matter was taken up during the 4th SEC (Haematology) meeting of 2025 held on April 8 at CDSCO headquarters, New Delhi. According to the official minutes,
“The firm presented protocol amendment version 05 dated 27 January 2025 protocol no. CVAY736I12301. After detailed deliberation, the committee recommended for approval of protocol amendment as presented by the firm.”
Ianalumab, a monoclonal antibody targeting BAFF-R, is under global investigation for a range of autoimmune and hematological conditions.
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