The approval by the European Commission was based on review of efficacy and safety data from Teva’s global development program, BREATH, in asthma. The clinical trial program consisted of five placebo-controlled studies. The program explored the efficacy and safety profile in a population of 1,028 adult and adolescent severe asthma patients treated with Cinqaero 3 mg/kg every four weeks that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies. Side effects included increased blood creatine phosphokinase, myalgia and anaphylactic reactions.
Cinqaero is a humanized interleukin-5 (IL-5) antagonist monoclonal antibody (IgG4 kappa). IL-5 is the most selective eosinophil-active cytokine and plays a major role in the maturation, activation and survival of eosinophils. In asthma patients, the eosinophilic phenotype is associated with compromised lung function, more frequent symptoms, and increased risk of exacerbations. Cinqaero binds to human IL-5 and prevents it from binding to the IL-5 receptor, thereby reducing eosinophilic inflammation.