However, the nod is subject to the condition that the dosing regimen shall be stratified across at least two distinct age groups and accordingly, statistical evaluation shall be performed to assess agespecific responses and dosing appropriateness.
Furthermore, it added, that in exclusion criteria, Latent Tuberculosis Infection (LTBI) shall be incorporated as part of the clinical protocol.
This came after MSN Laboratories presented the proposal for grant of permission to conduct Phase IV Clinical Trial Protocol vide protocol No. 010/TFCB-OS/MSN/2025, Version 1.0 dated 23.Apr.2025 before the Committee.
Tofacitinib is a Janus kinase (JAK) inhibitor used to treat rheumatic conditions, such as rheumatoid arthritis and ankylosing spondylitis, and ulcerative colitis.
Rheumatoid arthritis is an autoimmune disease characterized by a dysregulation of pro-inflammatory cytokines including IL7, IL15, IL21, IL6, IFN-alpha, and IFN-beta. Cytokines signalling results in tissue inflammation and joint damage by stimulating the recruitment and activation of immune cells via the janus kinase signalling pathway.
Tofacitinib is a partial and reversible janus kinase (JAK) inihibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signalling pathway is involved in the transcription of cells involved in hematopoiesis, and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response.
At the recent SEC meeting for Analgesic and Rheumatology, the expert panel reviewed the proposal presented by MSN Laboratories for a grant of permission to conduct Phase IV Clinical Trial Protocol vide protocol No. 010/TFCB-OS/MSN/2025, Version 1.0 dated 23.Apr.2025.
After detailed deliberation, the committee recommended for approval to conduct the Phase IV trial as per the protocol presented by the firm, subject to the condition that the Phase IV clinical trial protocol shall be revised to incorporate the following:
i. The dosing regimen shall be stratified across at least two distinct age groups, and accordingly, statistical evaluation shall be performed to assess age-specific responses and dosing appropriateness.
ii. In exclusion criteria, Latent Tuberculosis Infection (LTBI) shall be incorporated as part of the clinical protocol.
In line with the above, the expert panel suggested that the firm shall submit a revised Phase IV clinical trial protocol to CDSCO.
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