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CDSCO Panel approves Novartis Healthcare for selective use of Secukinumab dose up to 300 mg
![CDSCO Panel approves Novartis Healthcare for selective use of Secukinumab dose up to 300 mg CDSCO Panel approves Novartis Healthcare for selective use of Secukinumab dose up to 300 mg](https://medicaldialogues.in/h-upload/2024/02/17/750x450_232451-novartis-50.webp)
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.
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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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-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: editorial@medicaldialogues.in. Contact no. 011-43720751