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  • Generate PMS data to...

Generate PMS data to assess patient safety : CDSCO Panel Tells Novartis Healthcare on additional indications of Secukinumab

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-17T18:00:57+05:30  |  Updated On 17 March 2025 6:00 PM IST
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Novartis Healthcare to generate post-marketing surveillance (PMS) data of Secukinumab 150 mg/mL solution for injection in the country to assess patient safety for the indications of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

This came after Novartis Healthcare presented the justification for the waiver of the PMS study condition as part of the approval granted for additional indications of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

Psoriatic arthritis is a chronic inflammatory arthritis that affects some people with psoriasis, a skin condition, leading to joint pain, swelling, and stiffness, and can also affect nails and tendons. Ankylosing spondylitis (AS) is a chronic type of arthritis that causes inflammation in the spine and other parts of the body. It can lead to a hunched posture and stiffness. Non-radiographic axial spondyloarthritis (nr-axSpA) is a type of inflammatory arthritis affecting the spine and pelvis, characterized by inflammation that doesn't show up on X-rays but may be visible on MRI.

Secukinumab is a fully human monoclonal IgG1/κ antibody against interleukin-17A (IL-17A), a proinflammatory cytokine implicated in various chronic immune-mediated inflammatory disorders, such as plaque psoriasis. By blocking the actions of IL-17A, secukinumab works to inhibit the pro-inflammatory pathways that drive immune-mediated inflammatory disorders

Secukinumab injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. It is also used alone or together with other medicines (e.g., methotrexate) to treat active psoriatic arthritis.

At the recent SEC meeting for analgesics and rheumatology held on February 25, 2025, the expert panel reviewed the justification for the waiver of the PMS study condition as part of the approval granted for additional indications of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

After detailed deliberation, the committee reiterated its earlier recommendation for generating the PMS data in the country to assess patient safety for the indications of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

Also Read: Synokem Pharmaceutical Gets CDSCO Panel Nod To Study Anti-rheumatoid drug Iguratimod

Novartis healthcarecdscosecukinumabPsoriatic arthritisAnkylosing spondylitisnon radiographic axial spondyloarthritispost marketing surveillance
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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