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 clinical trial protocol amendment proposal of the drug major AstraZeneca Pharma India to study the long-term efficacy and safety of Tozorakimab in participants with chronic obstructive pulmonary disease with a history of exacerbation.
This came after the firm presented protocol amendment version 2.0 dated 27.07.2023, protocol no. D9180C00008 and Justification for amendment with respect to echocardiography.
The official title of the study 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 signaling, and epithelial dysfunction.
At the recent SEC meeting for Pulmonary, the expert panel reviewed the protocol amendment version 2.0 dated 27.07.2023, Protocol no. D9180C00008 and justification for the amendment with respect to echocardiography.
After detailed deliberation, the committee recommended for approval of protocol amendment, including amendment with respect to Echocardiography as presented by the firm.
