Phase III clinical trials with Cinquil (reslizumab) show positive results in asthma- Teva Pharma

Teva Pharmaceutical has presented results from a post-hoc analysis of two pivotal Phase III clinical trials showing that treatment with Cinquil (reslizumab) reduced clinical asthma exacerbations (CAEs) by 75% versus placebo in a subgroup of patients with late-onset asthma (diagnosed at 40 years of age and older) with elevated blood eosinophils, who were inadequately controlled on inhaled corticosteroids (ICS). In the overall pooled patient population, asthma exacerbations were reduced by 54%; in the subgroup of subjects diagnosed with asthma at <40 years of age, exacerbations were reduced by 42%.

Common adverse events (occurring in >5% of patients overall) in the reslizumab treatment group were comparable to placebo and included asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache. These results were presented as a late-breaking abstract at the 2015 ERS International Congress in Amsterdam.

Comment: the FDA has accepted for review the Biologics License Application (BLA) for reslizumab, for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils despite an inhaled corticosteroid (ICS)-based regimen.