CDSCO Panel Approves Novartis Protocol Amendment Proposal fo Ianalumab study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by Novartis for the clinical trial titled "A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA)"
This came after the firm presented protocol amendment version 05 dated 22 Aug 2024, protocol no. CVAY736O12301.
Ianalumab is a monoclonal antibody that is being investigated for autoimmune hepatitis, multiple sclerosis, pemphigus vulgaris, rheumatoid arthritis, Sjögren syndrome, and systemic lupus erythematosus.
Primary Sjögren's syndrome is a systemic autoimmune disorder commonly presenting with dryness involving the eyes and mouth due to inflammation and resultant pathology of the lacrimal and salivary glands.
Ianalumab 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.
Earlier, the Medical Dialogue Team had reported that the committee recommended the approval of the protocol amendment as presented by the firm with the condition that the study shall not be used to compare the efficacy and superiority of various delivery systems (PFS, autoinjector).
At the recent SEC meeting for Hematology held on 6th March 2025, the expert panel reviewed the protocol amendment version 05 dated 22 Aug 2024, protocol no. CVAY736O12301.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
