CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal for Tozorakimab Study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca's proposal for protocol amendment of the clinical trial titled "Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbation."
This came after the firm presented protocol no. D9180C00012, amendment version 2.0 dated 12 Jun 2024.
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the 12 months prior to enrolment.
Tozorakimab (MEDI3506), developed by AstraZeneca, was investigated in multiple clinical trials to evaluate its safety, tolerability, efficacy, and pharmacokinetics across various conditions.
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