Pfizer gets CDSCO panel nod to import, market Tofacintib for active ankylosing spondylitis

However, the approval is subjected to condition that the drug maker should conduct Phase IV clinical trial for the proposed indication.

This came after the firm presented their proposal for approval of the additional indication "Treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy" for already approved drug product Tofacitinib tablets 5mg before the committee.

Tofacitinib is an inhibitor of Janus kinases, a group of intracellular enzymes involved in signaling pathways that affect hematopoiesis and immune cell function. It is approved by the FDA for treatment of moderate to severe rheumatoid arthritis that responds inadequately to methotrexate or in those who are intolerant to methotrexate. Besides rheumatoid arthritis, tofacitinib has also been studied in clinical trials for the prevention of organ transplant rejection, and is currently under investigation for the treatment of psoriasis.

Tofacitinib is a Janus kinase (JAK) inhibitor used to treat rheumatic conditions, such as rheumatoid arthritis and ankylosing spondylitis, and ulcerative colitis.

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-γ signaling, which reduces CXCL10 chemokine expression,this helps in blocking the activity of vitiligo.

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.

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.

At the recent SEC meeting for Analgesic & Rheumatology held on 17th August 2022,the expert panel extensively evaluated Pfizer's proposal to import and market Tofacitinib for additional indication, "Treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy".

The committee noted that based on global clinical data and favorable risk benefit ratio, use of Tofacitinib tablets 5mg BID for Ankylosing Spondylitis (AS) has been approved in 37 countries including US, EU, UK and Taiwan.

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