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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.
Also Read: Cipla gets CDSCO Panel nod to study Revefenacin Inhalation solution
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751