Teva Announces Positive Results from Clinical Asthma Treatment Trials - Pharmaceutical Technology

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Teva Announces Positive Results from Clinical Asthma Treatment Trials


Teva Pharmaceutical Industries Ltd. announced on Sept. 2 that reslizumab, an investigational anti-IL-5 monoclonal antibody, demonstrated clear levels of efficacy in achieving the primary endpoint of reduction in the frequency of clinical asthma exacerbations (CAE) compared to placebo in two pivotal Phase III studies in patients with inadequately controlled moderate to severe asthma with elevated levels of blood eosinophils.

The studies included 953 patients across 232 medical centers worldwide including the US, EU, and the Far East. In both trials, reslizumab treatment showed both clinically relevant and statistically significant reductions in the frequency of CAE compared to placebo (50% and 60% respectively, p<0.0001 for both). Reslizumab has also demonstrated a positive effect on lung function and asthma control in the Phase III program. The combination of an effect on clinically important exacerbations and on improvements and preservation of lung function suggest that reslizumab may be a differentiated treatment for patients with moderate to severe asthma with elevated levels of blood eosinophils.

This initial set of results shows the adverse event profile of reslizumab was comparable to placebo in both trials. The incidence of common AEs (> 5%) was consistent with those seen in a moderate to severe asthma population, the most frequent being upper respiratory tract infections, asthma, and headache. Further analyses of additional efficacy and safety data are ongoing.

Source: Teva

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