Novartis Gets CDSCO panel okay To Study Monoclonal Antibody Ianalumab
New Delhi: The drug major Novartis has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the study of the monoclonal antibody Ianalumab.
However, the nod is subject to the condition that India-specific protocol the addendum is required to be submitted for including patients of overlap syndrome (patient satisfying criteria of >1 autoimmune rheumatic disease) in the study since the same is not mentioned in the clinical study protocol (CSP) under inclusion criteria.
This came after the firm presented justification for conducting the study of the monoclonal antibody Ianalumab before the committee.
Ianalumab 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. As of 2021, lanalumab is undergoing Phase II/III trials.
At the earlier meeting, responding to the proposal made by Novartis to conduct a Phase III clinical trial vide protocol number: CVAY736F12302, Version Number 00 (Original Protocol) dated 23 Aug 2022, the committee recommended that the applicant is required to revise the clinical study protocol (CSP) with respect to exclusion criteria- as follows- Patients with overlap syndromes, any subjects of SLE (Systemic lupus erythematosus) who is also positive for antiphospholipid antibodies, anticardiolipin, antib2gp1 and lupus anticoagulant, p- and c-ANCA, etc and have risk factors for thromboembolism should be excluded.
Accordingly, at the earlier SEC meeting, the expert panel stated that the applicant should submit a revised protocol to CDSCO for further review by the committee.
Now, in continuation, at the recent SEC meeting for Analgesic and Rheumatology held on 7th June 2023, the expert panel reviewed the justification for conducting the study of the monoclonal antibody Ianalumab presented by the drug major Novartis.
After detailed deliberation, the committee recommended the grant of permission for the conduct of the proposed study subject to the condition that India-specific protocol the addendum is required to be submitted for including patients of overlap syndrome (patient satisfying criteria of >1 autoimmune rheumatic disease) in the study since the same is not mentioned in the clinical study protocol (CSP) under inclusion criteria.
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