CDSCO Panel approves Novartis Healthcare for selective use of Secukinumab dose up to 300 mg
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-07-14 12:30 GMT | Update On 2024-07-14 12:30 GMT
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New Delhi: Reviewing the justification presented by the drug major Novartis Healthcare for the monoclonal antibody Secukinumab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to use the dose up to 300 mg only in patients who continue to have active psoriatic arthritis and active ankylosing spondylitis in line with USFDA-approved prescribing information (PI).
Further, the expert panel suggested generating post-marketing surveillance (PMS) data in the country to assess patient safety for the indications of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondylarthritis.
This came after Novartis Healthcare presented the justification for usage of a dose up to 300 mg based on clinical response for the product Secukinumab 150 mg/mL solution for injection in a pre-filled pen, along with the request for a waiver of the requirement to generate PMS data in the country for the indications of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
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 (eg, methotrexate) to treat active psoriatic arthritis.
At the recent SEC meeting for analgesics and rheumatology held on June 12th and 13th, 2024, the expert panel reviewed the justification for usage of doses up to 300 mg based on clinical response for the product Secukinumab 150 mg/mL solution for injection in a pre-filled pen, along with the request for a waiver of the requirement to generate PMS data in the country for the indications of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondylarthritis.
After detailed deliberation, the committee recommended the following:
1. The committee recommended the use of dose up to 300 mg only in patients who continue to have active Psoriatic Arthritis and active ankylosing spondylitis in line with USFDA-approved PI.2. The committee reiterated the 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 spondylarthritis.
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