Johnson and Johnson Gets CDSCO Panel nod for Additional Indication of Ustekinumab solution for injection
New Delhi: The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has granted approval to Johnson and Johnson for the proposed additional indication of Ustekinumab solution for injection 45 mg and 90 mg.
The approved additional indication of Ustekinumab solution for injection is for improving health-related quality of life in adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy of plaque psoriasis in adults.
However, the approval is subject to the condition to conduct a Phase IV trial in India in the proposed indication.
This came after the firm presented the additional safety data of South Asian subjects with plaque psoriasis in adults. The committee noted that the proposed additional indication is approved in the USA, UK, Japan, Singapore, Switzerland and other countries. The committee also noted that there is an unmet medical need in the country.
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 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.
At the recent SEC meeting for Dermatology and Allergy, the expert panel reviewed the presented additional safety data of South Asian subjects with plaque psoriasis in adults.
After detailed deliberation, the committee recommended the grant of approval for the proposed additional indication, i.e. for improving health-related quality of life in adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy of plaque psoriasis in adults with a condition to conduct a Phase IV trial in India in the proposed indication.
Accordingly, the expert panel suggested that the firm shall submit the Phase IV protocol to CDSCO within 03 months of approval of additional indication.
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