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

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.

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