Pfizer Gets CDSCO Panel Nod to Study PF-06823859

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-10-08 12:30 GMT | Update On 2024-10-08 12:30 GMT

Pfizer

New Delhi:The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial for the drug PF-06823859

This came after the firm presented phase 3 clinical study protocol no. C0251010 version original, dated 08 April 2024.

Dazukibart (PF-06823859) is under development for the treatment of moderate to severe dermatomyositis, cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus (SCLE), chronic cutaneous lupus erythematosus (CCLE), systemic lupus erythematosus.

PF-06823859 is a potent, selective, humanised immunoglobulin 1-neutralising monoclonal antibody (mAb) directed against human IFNβ. Dazukibart is a monoclonal antibody, a type of biologic drug specifically designed to target and inhibit certain proteins associated with autoimmune diseases.

Dazukibart targets the IL-23 cytokine, a protein that is heavily involved in the body's immune response. IL-23 plays a pivotal role in the development and maintenance of chronic inflammation, a hallmark of many autoimmune conditions.

At the recent SEC meeting for Analgesic and Rheumatology held on October 3, 2024, the expert panel reviewed phase 3 clinical study protocol no. C0251010 version original dated 08 April 2024.

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

Also Read: Exemed Pharmaceuticals gets CDSCO Panel nod to study Sacubitril plus Valsartan film-coated sustained release tablet

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Dr. Divya Colin

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.

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Pfizer Gets CDSCO Panel Nod to Study PF-06823859

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