CDSCO Panel Approves Novartis Protocol Amendment Proposal for Ianalumab Study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major Novartis protocol amendment proposal for the study of the monoclonal antibody drug VAY736 (Ianalumab).
This came after Novartis presented protocol amendment version 05 dated 28 August 2024 protocol no. CVAY736Q12301. This is a phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first-line steroid treatment (VAYHIT2).
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids. This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count \<30 G/L) who failed previous first-line treatment with corticosteroids.
After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.
Ianalumab is a monoclonal antibody that is being investigated for autoimmune hepatitis, multiple sclerosis, pemphigus vulgaris, rheumatoid arthritis, Sjögren syndrome, and systemic lupus erythematosus.
Ianalumab is a human antibody that targets the B-cell-activating factor receptor (BAFF-R). 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 hematology held on 10th December 2024, the expert panel reviewed protocol amendment version 05 dated 28 August 2024 protocol no. CVAY736Q12301.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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