Novartis gets CDSCO panel nod to study Ligelizumab in treatment of chronic inducible urticaria
New Delhi: Pharma major Novartis has got a go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase 3 clinical trial of Ligelizumab in the treatment of chronic inducible urticaria (CINDU) in adolescents and adults inadequately controlled with H1-Anti Histamines.
However, this approval is conditional on the inclusion of at least 50% government locations, and the firm should comply with the requirements for sampling of DNA biomarkers for pharmacogenomic study and its shipping to other countries.
This came after the firm presented the Phase III clinical trial protocol for Ligelizumab before the committee.
Ligelizumab is an IgE-directed monoclonal antibody under investigation for the treatment of chronic spontaneous urticaria (CSU).
Ligelizumab is currently under investigation for the treatment of chronic spontaneous urticaria (CSU), an autoimmune-driven inflammatory condition. While the precise pathogenesis of CSU is not entirely clear, autoantibodies against IgE receptors, and sometimes against IgE itself, are thought to exist in 30–40% of patients, and the efficacy of anti-IgE antibody therapy in the treatment of CSU has been previously established with omalizumab. Initial trials of ligelizumab suggest a greater efficacy than its predecessor for the treatment of CSU.
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