Conduct Phase-III clinical trial in India: CDSCO panel tells Johnson and Johnson Over Guselkumab
New Delhi: Citing that there is no clinical data available on the Indian Population, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Johnson and Johnson to conduct the phase III clinical trial of Guselkumab Solution for Injection 100 mg/ml in Single-use pre-filled syringe and Prefilled Pen.
This came after the firm presented safety data from the Phase-IV trial of other countries including Asian patients and ethnicity-wise data from the clinical trials conducted globally for considering the application for a grant of import and marketing permission with a local clinical trial waiver.
Guselkumab is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody that selectively blocks interleukin-23. IL-23 is an inflammatory cytokine that activates the CD4+ T-helper (Th17) cell pathway to mediate the inflammatory cascade that induces psoriatic plaque formation
Guselkumab injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. Additionally, the Janssen unit of Johnson & Johnson reported new data from its Phase 3b COSMOS trial for Tremfya (Guselkumab) that the interleukin (IL)-23 inhibitor showed sustained improvements across a range of outcomes in patients with active psoriatic arthritis (PsA).
At the recent SEC meeting for Analgesic and Rheumatology held on 8th August 2023, the expert panel reviewed the safety data from the Phase-IV trial of other countries including Asian patients, and ethnicity-wise data from the clinical trials conducted globally, presented by Johnson and Johnson.
After detailed deliberation, the committee noted that there is no clinical data available on the population of the Indian subcontinent.
In view of the above, the expert panel recommended conducting the Phase-III clinical trial in India. In addition, the expert panel suggested that the firm should submit the clinical trial protocol for review.
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