CDSCO Panel Approves AstraZeneca pharma's Protocol Amendment proposal to study Anifrolumab

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-01T17:00:17+05:30 | Updated On 1 July 2024 5:00 PM IST

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major AstraZeneca Pharma India's protocol amendment proposal to study anifrolumab.

This came after the firm presented protocol amendment version 3.0 dated 07. 3. 2024 protocol no. D3460C00002. The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis.

Anifrolumab is a monoclonal antibody that inhibits type 1 interferon receptors and is indicated for treating moderate to severe systemic lupus erythematosus. This binding inhibits type I IFN signaling, thereby blocking the biological activity of type I IFNs. Anifrolumab-final also induces the internalization of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly.

Systemic sclerosis, or scleroderma, is a rare connective tissue disorder with an unknown and complex pathogenesis. The pathophysiology of systemic sclerosis is intricate and not entirely understood. The disease is characterized by 3 main hallmarks: vascular insult, autoimmunity, and tissue fibrosis.

At the recent SEC meeting for analgesics and rheumatology held on June 12 and 13, 2024, the expert panel reviewed protocol amendment version 3.0 dated 07. 3. 2024 protocol no. D3460C00002.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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anifrolumabcdscoastrazeneaastrazeneca pharma indiaprotocol amendmentsystemic sclerosis

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-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