Novartis Phase III CT protocol for Lanalumab Rejected by CDSCO Panel
New Delhi: Citing that the clinical trial protocol missed some inclusion/exclusion criteria, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has rejected Novartis Healthcare's Phase III clinical trial protocol for monoclonal antibody Ianalumab.In addition to this, the expert panel has opined the drug maker Novartis to present the protocol...
New Delhi: Citing that the clinical trial protocol missed some inclusion/exclusion criteria, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has rejected Novartis Healthcare's Phase III clinical trial protocol for monoclonal antibody Ianalumab.
In addition to this, the expert panel has opined the drug maker Novartis to present the protocol in detail to CDSCO for further review. This came after the firm presented Phase III clinical trial protocol before the committee.
Lanalumab is a monoclonal antibody that is being investigated for autoimmune hepatitis, multiple sclerosis, pemphigus Vulgaris, rheumatoid arthritis, Sjogren's syndrome, and systemic lupus erythematosus.
Lanalumab is an anti-B-cell activating factor (BAFF) receptor antibody which is administered subcutaneously. The Phase II study (NCT03287414) trial was originally anticipated to recruit 84 IPF patients but stopped accrual at 30 patients, as per a 10 May update on the study's ClinicalTrials.gov entry. The trial was started in December 2017. While the trial has completed, as per an update earlier this week, results have not yet been posted. This was a placebo-controlled study meant to evaluate lanalumab's impact on the forced vital capacity (FVC) over a 48-week time frame. Once the trial completed, the drug's Likelihood of Approval (LoA) also increased to 13% with a 3-point increase.
At the recent SEC meeting for Cardiovascular and Renal held on 19.07.2022, the expert panel reviewed the proposal for Phase III clinical trial of lanalumab protocol in detail.
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