Submit Additional Safty Data: CDSCO Tells J&J on Ustekinumab solution for injection
New Delhi: In response to the drug major Johnson & Johnson's proposal of Ustekinumab solution for injection for additional indication, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit the additional safety data on Indian patients through a Phase IV study for the approved indication (Crohn’s disease) for further consideration of the present application.
This came after Johnson & Johnson presented its proposal for the additional indication of Ustekinumab solution for injection for subcutaneous administration in prefilled syringes 45mg/0.5ml, 90 mg/ml, and Ustekinumab Solution for intravenous infusion in the single-use vial 130 mg/26 ml with local clinical trial waiver before the committee.
Ustekinumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Ustekinumab prevents human IL-12 and IL-23 from binding to the IL-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of NK and T cells.
Ustekinumab is used to treat plaque psoriasis, a specific type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). It works by blocking specific natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions
Earlier, Medical Dialogues Team had reported that CDSCO had approved to conduct Phase IV trial of Ustekinumab pre-filled syringe 45mg/0.5ml, 90mg/ml, and single-use vial 130mg/26ml.
At the recent SEC meeting for Gastroenterology and Hepatology held on 18th April 2023, the expert panel reviewed the proposal presented by the firm for an additional indication of Ustekinumab solution for injection for subcutaneous administration in prefilled syringes 45 mg/0.5ml, 90 mg/ml and Ustekinumab Solution for intravenous infusion in the single-use vial 130 mg/26 ml with the local clinical trial waiver.
After detailed deliberation, the committee recommended that the firm is required to submit additional safety data on Indian patients through a Phase IV study for the approved indication (Crohn’s disease) for further consideration of the present application for an additional indication.
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