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.
Earlier the Medical Dialogues Team had reported that Ligelizumab, an investigational treatment for chronic spontaneous urticaria (CSU), had failed to show superiority to omalizumab in two identical phase 3 trial.
Novartis announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab.
At the recent SEC meeting, in response to the drug maker Novartis' proposal to conduct a phase 3 clinical trial of Ligelizumab, specifying the risk versus benefit to the patients, the committee noted that the safety profile of the trial drug from various pre-clinical toxicity studies and clinical studies, may justify the conduct of the proposed trial.
In addition, analysing the innovation vis-a-vis existing therapeutic options, the SEC meeting minutes added, "The purpose of the study is to investigate the efficacy and safety of Ligelizumab (QGE031) in the treatment of chronic inducible urticaria (CINDU) in adolescents and adults inadequately controlled with H1-Anti Histamines."
In line with the unmet medical need in the country, the expert panel further observed that, the trial drug may be an alternative treatment option for chronic inducible urticaria (CINDU) in adolescents and adults inadequately controlled with H1-Anti Histamines.
After detailed deliberation, the committee recommended the grant of permission to conduct the study with the following conditions:
1. At least 50% of government websites should be included.
2. The firm should comply with the requirements for sampling of DNA biomarkers for pharmacogenomic study and their shipping to other countries.
