Ohtuvayre: animal efficacy model or human cells?

“However, the Applicant did not conduct any in vivo pharmacology studies using COPD animal models. The in vivo pharmacology studies were primarily for allergic conditions as well as asthma.”

“While there are no animal models that fully recapitulate all aspects of COPD, the most frequently employed animal models use cigarette smoke, lipopolysaccharide, and elastase to induce various features of COPD.”

“Given the differences in etiology between COPD and allergic conditions, the clinical relevance of these studies to the current application is not clear. Nevertheless, the totality of in vitro and in vivo pharmacology data submitted was considered sufficient to characterize the pharmacological activity of ensifentrine”