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  • Sun Pharma Gets CDSCO...

Sun Pharma Gets CDSCO Panel Nod to Study Tildrakizumab Injection 100 mg/ ml

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-02-16T18:00:15+05:30  |  Updated On 22 March 2024 9:25 PM IST
Sun Pharma scores USFDA nod for Next Generation BLU-U Blue Light Photodynamic Therapy Illuminator for Actinic Keratosis
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New Delhi: The drug major Sun Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of Tildrakizumab injection, a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders.

This came after the drug major Sun Pharma presented phase 3 clinical study protocol no. TILD-21.01, amendment 2 dated 9th November 2023.

Tildrakizumab is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis.

This drug selectively binds interleukin (IL)-23 p19 subunit of cytokine IL-23 and neutralizes its function IL-23 regulates Th17 cells and is a powerful activator of keratinocyte proliferation. Targeting IL-23p19 alone is a promising treatment approach in patients with moderate-to-severe chronic plaque psoriasis. Upon administration, downregulation of Th17 and Th22 cell responses occurs.

IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

At the recent SEC meeting for Analgesic and Rheumatology held on the 6th of February 2024, the expert panel reviewed the Phase III clinical study of the drug Tildtildrakizumab injection.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

Also Read:Indiscreet prescribing of antibiotics is key contributor to microbial resistance nationwide: MoS Health

sun pharmacdscotildrakizumabmonoclonal antibodysun pharma news
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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