CDSCO Panel Approves Novartis's Protocol Amendment Proposal to Study Ianalumab
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis' protocol amendment proposal for the clinical study titled, “A randomized, double-blind 2-ann NEPTUNUS extension study to assess the long-term safety and efficacy of ianalumab in patients with Sjogren's syndrome."
This came after the firm presented protocol amendment version 02 dated 24 July 2024 protocol no. CVAY736A2301E1.
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 Sjogren 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 (previously known as VAY736) 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.
At the recent SEC meeting for analgesics and rheumatology held on 3rd October 2024, the expert panel reviewed the protocol amendment version 02 dated 24 July 2024 protocol no. CVAY736A2301E1.
After detailed deliberation, 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).
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