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

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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