CDSCO panel approves Intas pharma to continue Tofacitinib Ointment 2% CT Study
New Delhi: Citing that drug maker, Intas Pharma should report in case of any Serious Adverse Events (SAEs) related to the Phase III clinical trial of Tofacitinib Ointment 2%, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the continuation of the clinical trial of the drug Tofacitinib Ointment 2% as per the approved protocol.
This came after the firm presented the study data of the first 50 patients enrolled in a Phase III clinical trial in accordance with the earlier SEC recommendation dated July 27, 2022.
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, 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-γ 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 immunosuppressive agents such as azathioprine or cyclosporine.
The inhibition of JAKs can simultaneously block the function of multiple cytokines. Therefore, JAK inhibitors are emerging as a new class of drugs, which in dermatology can either be used systemically as oral drugs or locally in topical formulations.
Earlier, the Medical Dialogues Team had reported that the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) had granted its nod to conduct a Phase III clinical trial of Tofacitinib Ointment 2%.
However, this nod was subjected to conditions that post-trial access to the standard of care for the patients should be included in the clinical trial protocol for the patients' safety. Furthermore, the conditions included that the firm should present the data of the first 50 patients (equally distributed in each arm) enrolled in the study for review by the committee, prior to further recruitment of the patients in the clinical trial.
At the recent SEC meeting for Dermatology and Allergy, the expert panel reviewed the study data of the first 50 patients enrolled in a Phase III clinical trial presented by drug maker Intas Pharma.
In view of the above, the Committee noted that there is no safety signal in first 50 patients.
After detailed deliberation, the committee recommended that the firm may continue the clinical trial as per approved protocol. In addition, the expert panel directed that the firm should report CDSCO in case of any Serious Adverse Events (SAEs) related to clinical trial.
