Sun Pharma Gets CDSCO panel nod for active post marketing surveillance of Tofacitinib ER Tablets
New Delhi: Pharmaceutical major, Sun Pharma has got the green signal from the Subject Expert Panel (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct active post marketing surveillance (PMS) of Tofacitinib which is used for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
This came after the firm presented its proposal for an active PMS study protocol titled “A multi-centric, active post-marketing surveillance study to assess the safety and efficacy of Tofacitinib extended-release tablets 11mg for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis” 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.
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.
Earlier, the Medical Dialogues Team had reported that the Central Drugs Standard Control Organization (CDSCO) panel had granted approval to pharma major Sun Pharmaceuticals to manufacture and market Tofacitinib ER Tablets 11mg for the treatment of Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis.
In continuation with the above, at the recent SEC meeting for Analgesic & Rheumatology held on 12th January 2023, the expert panel reviewed the proposal presented by the firm for an active PMS study protocol titled “A multi- centric, active post-marketing surveillance study to assess the safety and efficacy of Tofacitinib extended-release tablets 11mg for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis” before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct the active PMS study as per the protocol presented.
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