Submit safety data on South Asian subjects with Plaque Psoriasis: CDSCO Panel Tells Johnson & Johnson on Ustekinumab
New Delhi: In line with the proposal presented by the drug major Johnson and Johnson proposal for approval of additional indication with waiver of Phase III and Phase IV clinical trials for Ustekinumab solution for injections 45 mg and 90 mg (Stelara), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit more safety data of Ustekinumab in South Asian subjects with plaque psoriasis in adults.
This came after Johnson & Johnson presented the proposal for approval of additional indication with the waiver of Phase III and Phase IV clinical trials for Ustekinumab solution for injection 45 mg and 90 mg (Stelara) for indication of plaque psoriasis in adults based on the global clinical data generated from other countries.
Plaque psoriasis is an autoimmune condition that causes dry, raised, itchy, scaly patches (plaques) on the skin. It's the most common type of psoriasis and can appear anywhere on the body, but most often on the scalp, elbows, knees, and lower back.
Ustekinumab is a human monoclonal antibody typically used to treat moderate to severe plaque psoriasis, psoriatic arthritis, moderate to severe Crohn disease, or moderate to severe ulcerative colitis (inflammatory bowel disease).
Ustekinumab mechanism of action. Ustekinumab binds to the p40 subunit of interleukin (IL)-12 and IL-23 and prevents their interaction with the cell surface IL-12Rβ1 receptor, subsequently inhibiting IL-12- and IL-23-mediated cell signaling, activation, and cytokine production (image not drawn to scale).
At the recent SEC meeting for dermatology and allergy held on 5th September 2024, the expert panel reviewed the proposal for approval of additional indication with a waiver of Phase III and Phase IV clinical trials for Ustekinumab solution for injection 45mg and 90mg (Stelara) for indication of plaque psoriasis in adults based on the global clinical data generated from other countries.
After detailed deliberation, the committee recommended the firm submit more safety data on South Asian subjects with Plaque Psoriasis in Adults for further evaluation.
