CDSCO Panel Grants Novartis Protocol Amendment Proposal For 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 drug Ianalumab (VAY736).

This came after Novartis presented protocol amendment version 03 dated 27 Apr 2023 and protocol amendment 04 dated 14 Dec 2023, protocol No. CVAY736I12301. The above study is a phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (VAYHIT1).

This is a study of ianalumab (VAY736) in addition to first-line corticosteroids in patients with primary immune thrombocytopenia.

Ianalumab (VAY736) is a monoclonal antibody that is being investigated for autoimmune hepatitis, multiple sclerosis, pemphigus vulgaris, rheumatoid arthritis, Sjögren syndrome, and systemic lupus erythematosus. This drug is being developed by Novartis. In 2021 ianalumab was undergoing Phase II/III trials.

Ianalumab is a fully human mAb that targets BAFF-R. It has a novel dual mechanism of action: blockade of BAFF-R-mediated signaling and potent depletion of B cells mediated by antibody-dependent cellular cytotoxicity.

At the recent SEC meeting for Hematology held on 18th April 2024, the expert panel reviewed protocol amendment version 03 dated 27 Apr 2023, and protocol amendment 04 dated 14 Dec 2023, protocol No. CVAY736I12301.

After detailed deliberation, the committee recommended the approval of protocol amendments as presented by the firm.

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