CDSCO Panel Approves AstraZeneca's protocol amendment proposal for COPD drug Tozorakimab

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major AstraZeneca's Proposal for the amendment of the Protocol titled "Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease with a History of Exacerbations".

This came after the firm presented protocol amendment version 3.0 dated 26.03.2024 protocol no. D9180C00008. This is a phase III, multicentre, randomised, double-blind, chronic-dosing, parallel-group, placebo-controlled extension study to evaluate the long-term efficacy and safety of Tozorakimab in participants with chronic obstructive pulmonary disease (COPD) with a history of exacerbations (PROSPERO).

Tozorakimab is a human monoclonal antibody that neutralizes interleukin (IL)-33. IL-33 is a broad-acting epithelial “alarmin” cytokine upregulated in the lung tissue of patients with chronic obstructive pulmonary disease (COPD).

Tozorakimab directly neutralizes IL-33red inflammatory activities at the ST2 receptor. The IL-33red–tozorakimab complex prevents the oxidation of IL-33, IL-33ox–RAGE/EGFR signalling and epithelial dysfunction.

At the recent SEC meeting for pulmonary, the expert panel reviewed the protocol amendment version 3.0 dated 26.03.2024 protocol no. D9180C00008.

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

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