CDSCO Panel grants Pfizer's protocol amendment proposal for Tofacitinib
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment for the long-term safety study of Tofacitinib in patients with Juvenile Idiopathic Arthritis (JIA).
This recommendation came after the drug major Pfizer presented protocol amendment 12 dated 06-05-2022 for protocol no A3921145 (Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis) before the committee.
Tofacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It acts by decreasing the activity of the immune system.It is used to treat rheumatic conditions,such as rheumatoid arthritis and ankylosing spondylitis, and ulcerative colitis.
Topical Tofacitinib is used for the Treatment of Vitiligo in adolescent patients.Since it is a JAK1 and JAK3 inhibitor that interferes with interferon- signaling, which reduces CXCL10 chemokine expression, this helps in blocking the activity of vitiligo.
Tofacitinib inhibits Janus kinases, a group of intracellular enzymes involved in signalling pathways that affect hematopoiesis and immune cell function.Tofacitinib is indicated for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis (RA), active psoriatic arthritis, active ankylosing spondylitis, or moderately-to-severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF( tumor necrosis factor) blockers.
Tofacitinib is not recommended to be used in combination with other biologic disease-modifying anti-rheumatic drugs (DMARDs) or potent immunosuppressiveagents such as azathioprine or cyclosporine.
At the recent SEC meeting for the Analgesic and Rheumatoloy held on 14th December 2022, the expert panel reviewed the presentation for the protocol amendment 12 dated 06-05-2022 for protocol no A3921145.
After detailed deliberation, the committee recommended the approval of proposed protocol amendment.
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