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 prevents human IL-12 and
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
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.
Also Read:Akums gets CDSCO Panel nod for Phase III CT of FDC Moxifloxacin, Nepafenac ophthalmic solution
