PETAH TIKVA (dpa-AFX) - Teva Pharmaceutical Industries Ltd. (TEVA) announced 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 or 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.
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 uniquely 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.
The company plans to submit applications for approval in the US, Europe and other regions as soon as possible.
The results announced today provide a strong foundation for investigation of additional indications, such as COPD with elevated eosinophils. The ongoing development of a subcutaneous formulation will further strengthen the franchise and is expected to be submitted for approval in the second half of 2017.
These new data are from two global Phase III 12-month, randomized, double-blind, placebo-controlled, parallel-group studies, evaluating the efficacy and safety of intravenously administered reslizumab (3.0 mg/kg) once every four weeks, compared to placebo in asthma patients (12-75 years of age with elevated blood eosinophils) that are inadequately controlled by standard of care therapy.
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