CDSCO Panel Approves Sanofi's Protocol Amendment proposal for COPD drug Itepekimab
New Delhi: The Subject Expert Panel (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Sanofi's protocol amendment proposal for the clinical study to assess the efficacy, safety, and tolerability of SAR440340/REGN3500/ Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-1).
This came after the firm presented protocol 02, version 01 dated 27-Sep-2023, protocol No. EFC16750. This study is a randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Itepekimab is a monoclonal antibody that targets interleukin (IL-33) and has been shown to reduce airway inflammation and associated tissue damage in preclinical studies.
Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in Chronic Obstructive Pulmonary Disorder (COPD).
At the recent SEC meeting for Pulmonary held on 4th January 2024, the expert panel reviewed protocol 02, version 01 dated 27-Sep-2023, protocol No. EFC16750 was presented by the drug major Sanofi.
After detailed deliberation, the committee recommended the approval of the proposed protocol amendment as presented by the firm.
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