Include more Govt sites: CDSCO panel to Sanofi on clinical trial of pulmonary disease drug
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted permission to Sanofi to conduct the Clinical Trial of SAR440340/REGN3500.
However, permission has been granted based on the condition that the firm should include more government sites across India.
To reach the medical need of providing treatment in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD); the firm presented the proposed global Phase III clinical trial before the committee at the 50th SEC meeting ((Pulmonary) held on 26.02.2021& 01.03.2021 at CDSCO HQ New Delhi.
Further, it was stated that in terms of assessment of risk vs. benefit to the patients, the safety profile of the study drugs from preclinical toxicology studies including Single-Dose Toxicity, repeat dose toxicity, Phase I and III clinical study justify the conduct of the trial.
The purpose of the study is to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (antiIL-33mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
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